42
Highlights of Changes This Week at ClinicalTrials.gov: New Sponsors: Six sponsors registered studies at ClinicalTrials.gov for the first time this week. Those sponsors are Argentum Medical, Glycom, Kang Stem Holdings, Minneamrita Therapeutics, Seragon Pharmaceuticals and Vidara Therapeutics Research. For more details, see New Sponsors on Page 2. New Studies: Sixty-nine new studies were registered this week, including studies sponsored by Amgen, AstraZeneca, Bayer, Boeh- ringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Novo Nordisk and Shire. For more details, see New Studies on Page 2. New Results: Twenty-seven industry-sponsored studies posted results this week, including studies by AstraZeneca, Bausch & Lomb, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Johnson & Johnson, Merck and Pfizer. For more details, see New Results on Page 6. New Study Status: One hundred and one studies are reporting changes in their status as planning, recruiting, ongoing or completed this week. Among the sponsors are Abbott, AbbVie, AstraZeneca, Bausch & Lomb, Bristol-Myers Squibb, Celgene, Cubist, Eli Lilly, Genentech, Gil- ead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Mannkind, Med- Immune, Medtronic, Novo Nordisk, Otsuka, Pfizer, Sanofi, Takeda, Teva and Vertex. For more details, see New Study Status on Page 7 . Vol. 2, No. 35 Aug. 29, 2013 New Sponsors .......... Page 2 New Studies ............. Page 2 New Results ............. Page 6 New Study Status..... Page 7 Studies Opening a First Site in a New Country ...Page 12 Studies Opening Additional Sites in a Country ..Page 21 Study Sites by Country .................. Page 39 Studies Under Planning ................. Page 40 Studies Ended or Halted..................... Page 41 INSIDE THIS ISSUE SUMMARY OF LATEST TRIAL UPDATES Week Ending Aug. 29 Aug. 22 Aug. 15 Aug. 8 Total New Sponsors 6 12 8 12 38 New Studies 69 107 62 105 343 New Results 27 33 38 38 136 New Study Status 101 96 92 100 389 Studies Opening a First Site in a New Country 224 277 269 323 1,093 Studies Opening Additional Sites in a Country 397 597 867 479 2,340 Studies Under Planning 46 49 49 50 194 Studies Ended or Halted 23 14 12 11 60 (See Highlights, Page 2)

INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

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Page 1: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

Highlights of Changes This Week at ClinicalTrials.gov:New Sponsors: Six sponsors registered studies at ClinicalTrials.gov for the first time this week. Those sponsors are Argentum Medical, Glycom, Kang Stem Holdings, Minneamrita Therapeutics, Seragon Pharmaceuticals and Vidara Therapeutics Research. For more details, see New Sponsors on Page 2.

New Studies: Sixty-nine new studies were registered this week, including studies sponsored by Amgen, AstraZeneca, Bayer, Boeh-ringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Novo Nordisk and Shire. For more details, see New Studies on Page 2.

New Results: Twenty-seven industry-sponsored studies posted results this week, including studies by AstraZeneca, Bausch & Lomb, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Johnson & Johnson, Merck and Pfizer. For more details, see New Results on Page 6.

New Study Status: One hundred and one studies are reporting changes in their status as planning, recruiting, ongoing or completed this week. Among the sponsors are Abbott, AbbVie, AstraZeneca, Bausch & Lomb, Bristol-Myers Squibb, Celgene, Cubist, Eli Lilly, Genentech, Gil-ead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Mannkind, Med-Immune, Medtronic, Novo Nordisk, Otsuka, Pfizer, Sanofi, Takeda, Teva and Vertex. For more details, see New Study Status on Page 7.

Vol. 2, No. 35Aug. 29, 2013

New Sponsors ..........Page 2

New Studies .............Page 2

New Results .............Page 6

New Study Status .....Page 7

Studies Opening a First Site in a New Country ...Page 12

Studies Opening Additional Sites in a Country ..Page 21

Study Sites by Country ..................Page 39

Studies Under Planning .................Page 40

Studies Ended or Halted .....................Page 41

INsIde thIs Issue

SummAry of lATeST TriAl updATeS

Week ending Aug. 29 Aug. 22 Aug. 15 Aug. 8 Total

New Sponsors 6 12 8 12 38New Studies 69 107 62 105 343New Results 27 33 38 38 136New Study Status 101 96 92 100 389Studies Opening a First Site in a New Country 224 277 269 323 1,093Studies Opening Additional Sites in a Country 397 597 867 479 2,340Studies Under Planning 46 49 49 50 194Studies Ended or Halted 23 14 12 11 60

(See Highlights, Page 2)

Page 2: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 2

Studies Opening a First Site in a New Country: Two hundred and twenty-four new study sites launched this week in countries where the sponsors did not have study sites. For more details, see Studies Opening a First Site in a New Country on Page 12.

Studies Opening Additional Sites in a Country: Three hundred and ninety-seven new study sites launched this week in countries where the sponsors already had study sites. For more details, see Studies Opening Additional Sites in a Country on Page 21.

Study Sites by Country: A handy table that lists all countries with first-time and additional study sites that launched this week can be found at Study Sites by Country on Page 39.

Studies Under Planning: About 10% of the studies listed as in the planning stage are replaced each week. This week’s 46 listings include planned studies at AstraZeneca, Bristol-Myers Squibb, Celgene, Glaxo- SmithKline, Janssen, Medtronic, Merck, Novartis, Pfizer, and Zimmer. For more details, see Studies Under Planning on Page 40.

Studies Ended or Halted: Twenty-three studies were terminated, suspended or withdrawn this week, including studies sponsored by Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Merck, Novartis and Teva. For more details, see Studies Ended or Halted on Page 41.

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01927705 KANG STEM GENETIC 1. PLANNING 1 3020

YEARS60

YEARSATOPIC DERMATITIS

NCT01927900 GLYCOMDIETARY SUP.

1. PLANNING NA 10018

YEARS60

YEARSGASTROINTESTINAL SYMPTOMS

NCT01823835 SERAGON DRUG 2. RECRUITING 1 7218

YEARSN/A BREAST CANCER

NCT01927211 ARGENTUM DEVICE 2. RECRUITING NA 66018

YEARSN/A POST-OPERATIVE PAIN

NCT01927965 MINNEAMRITA DRUG 3. ONGOING 1 5418

YEARSN/A

GASTROINTESTINAL TUMORS

NCT01929382 VIDARA DRUG 3. ONGOING 1 4018

YEARS55

YEARSHEALTHY

Highlights, from Page 1

NeW SpoNSorS

This table lists new sponsors that have never previously registered studies at ClinicalTrials.gov.

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

NeW STudieS

This table lists every new study registered in the past week.

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01926509 MERCK DRUG 1. PLANNING 1 1818

YEARS70

YEARSPULMONARY HYPERTENSION

NCT01927224 BAYER DRUG 1. PLANNING 1 3618

YEARS45

YEARSCHAGAS DISEASE

(See New Studies, Page 3)(Return to Page 1)

Page 3: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 3

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01927341 NOVARTIS DRUG 1. PLANNING 1 9018

YEARSN/A

METASTATIC COLORECTAL CANCER

NCT01927705 KANG STEM GENETIC 1. PLANNING 1 3020

YEARS60

YEARSATOPIC DERMATITIS

NCT01928394 BMS BIOLOGICAL 1. PLANNING 1 16018

YEARSN/A SOLID TUMORS

NCT01928459 NOVARTIS DRUG 1. PLANNING 1 5518

YEARSN/A

METASTATIC SOLID TUMORS

NCT01928472 NOVARTIS BIOLOGICAL 1. PLANNING 1 40018

YEARS64

YEARSH7N9 INFLUENZA

NCT01928563 DONG-A DRUG 1. PLANNING 1 2420

YEARS45

YEARSHEALTHY

NCT01928862 FERRING DRUG 1. PLANNING 1 759

YEARS16

YEARSBOWEL PREPARATION

NCT01929109 ELI LILLY DRUG 1. PLANNING 1 6018

YEARS85

YEARS

RENAL INSUFFICIENCY, CHRONIC

NCT01929330 GSK DRUG 1. PLANNING 1 3618

YEARS65

YEARSALOPECIA

NCT01926847 BAYER DRUG 1. PLANNING 2 2018

YEARS70

YEARSRAYNAUD DISEASE

NCT01927198 ARDEA DRUG 1. PLANNING 2 16018

YEARS70

YEARSGOUT

NCT01927419 BMS BIOLOGICAL 1. PLANNING 2 15018

YEARSN/A MELANOMA

NCT01927913 SHIRE DRUG 1. PLANNING 2 5018

YEARSN/A

METABOLIC DISEASES

NCT01928381 ASTRAZENECA DRUG 1. PLANNING 2 6518

YEARS75

YEARSDIABETIC NEUROPATHY

NCT01928615HOFFMANN-LA ROCHE

DRUG 1. PLANNING 2 5018

YEARSN/A BREAST CANCER

NCT01928901 BIONORICA DRUG 1. PLANNING 2 5625

YEARS40

YEARSCURRENT SMOKERS

NCT01926782 REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLESTER-OLEMIA

NCT01926886HOFFMANN-LA ROCHE

DRUG 1. PLANNING 3 10018

YEARSN/A BREAST CANCER

NCT01927055 CHELSEA DRUG 1. PLANNING 3 45018

YEARSN/A

DOPAMINE DEFICIENCY

NCT01928771 ASTRAZENECA BIOLOGICAL 1. PLANNING 3 1,13418

YEARS75

YEARSASTHMA

NCT01929044BOEHRINGER INGELHEIM

DRUG 1. PLANNING 3 29618

YEARS70

YEARSINTESTINAL DISEASES

NCT01929317 GSK DRUG 1. PLANNING 3 8020

YEARSN/A

PARKINSON DISEASE

(See New Studies, Page 4)

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

New Studies, from Page 2

Page 4: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 4

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01926496 LEO DRUG 1. PLANNING 4 48018

YEARSN/A ACTINIC KERATOSIS

NCT01926951 KONA DEVICE 1. PLANNING NA 2018

YEARSN/A HYPERTENSION

NCT01927575 FUJIFILM DEVICE 1. PLANNING NA 3018

YEARSN/A HIP INJURY

NCT01927900 GLYCOMDIETARY SUP.

1. PLANNING NA 10018

YEARS60

YEARSGASTROINTESTINAL SYMPTOMS

NCT01928875GE HEALTHCARE

DEVICE 1. PLANNING NA 50018

YEARS80

YEARSSURGICAL INTERVENTION

NCT01928979 BAYER OTHER 1. PLANNING NA 15018

YEARSN/A ATRIAL FIBRILLATION

NCT01929291 GSK BIOLOGICAL 1. PLANNING NA 60011

YEARS64

YEARSADVERSE EVENTS BOOSTRIX

NCT01926587 ONCONOVA DRUG 2. RECRUITING 1 4018

YEARSN/A

CHRONIC MYELOMONOCYTIC LEUKEMIA

NCT01928147 PRESIDIO DRUG 2. RECRUITING 1 14418

YEARS65

YEARSHEPATITIS C, CHRONIC

NCT01928368 AMGEN DRUG 2. RECRUITING 1 9618

YEARS45

YEARSASTHMA

NCT01929213 DONG-A DRUG 2. RECRUITING 1 3020

YEARS45

YEARSHEALTHY

NCT01929226 ELUSYS BIOLOGICAL 2. RECRUITING 1 28018

YEARSN/A

INHALATIONAL ANTHRAX

NCT01926444 GICARE DRUG 2. RECRUITING 2 24040

YEARS70

YEARSCOLONIC DISEASES

NCT01928433 MERLION DRUG 2. RECRUITING 2 25818

YEARSN/A

ACUTE PYELONEPHRITIS

NCT01928940 GSK DRUG 2. RECRUITING 2 1220

YEARSN/A SOLID TUMOURS

NCT01929096JIANGSU SIMCERE

DRUG 2. RECRUITING 2 40035

YEARS75

YEARSACUTE ISCHEMIC STROKE

NCT01927263 NICHI-IKO BIOLOGICAL 2. RECRUITING 3 23020

YEARS75

YEARSRHEUMATOID ARTHRITIS

NCT01927861 NOVO NORDISK DRUG 2. RECRUITING 3 483

YEARS11

YEARSNOONAN SYNDROME

NCT01928537 ONCONOVA DRUG 2. RECRUITING 3 9018

YEARSN/A CYTOPENIA

NCT01929031BOEHRINGER INGELHEIM

DRUG 2. RECRUITING 3 56018

YEARS55

YEARSTOOTH DISEASES

NCT01926912 JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01927757 AMGEN BIOLOGICAL 2. RECRUITING 4 25018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01926873HOFFMANN-LA ROCHE

2. RECRUITING NA 24018

YEARS65

YEARSHEALTHY

New Studies, from Page 3

(See New Studies, Page 5)

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

Page 5: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 5

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01927068 COVIDIEN DEVICE 2. RECRUITING NA 50018

YEARSN/A

PERIPHERAL ARTERIAL DISEASE

NCT01927211 ARGENTUM DEVICE 2. RECRUITING NA 66018

YEARSN/A

POST-OPERATIVE PAIN

NCT01927679 INNOVADERM DRUG 2. RECRUITING NA 1018

YEARSN/A

PIGMENTATION FROM VISIBLE LIGHT

NCT01928953 ASTRAZENECA 2. RECRUITING NA 90018

YEARS85

YEARS

OPIOID INDUCED CONSTIPATION

NCT01929369 VOLCANO 2. RECRUITING NA 10018

YEARS85

YEARSTHROMBOSED AV GRAFTS

NCT01927965 MINNEAMRITA DRUG 3. ONGOING 1 5418

YEARSN/A

GASTROINTESTINAL TUMORS

NCT01929382 VIDARA DRUG 3. ONGOING 1 4018

YEARS55

YEARSHEALTHY

NCT01929200 ZHEJIANG DRUG 3. ONGOING 2 12018

YEARS75

YEARSNON-SMALL-CELL LUNG CANCER

NCT01926548 CORPORATION DRUG 4. COMPLETED 1 2820

YEARS55

YEARSHEALTHY

NCT01926652 SHIN POONG DRUG 4. COMPLETED 1 3420

YEARS55

YEARSHEALTHY

NCT01928056 TORRENT DRUG 4. COMPLETED 1MISS-ING

18 YEARS

45 YEARS

HEALTHY

NCT01928069 TORRENT DRUG 4. COMPLETED 1MISS-ING

18 YEARS

45 YEARS

HEALTHY

NCT01928316 XIAN-JANSSEN DRUG 4. COMPLETED 1 2418

YEARS40

YEARSHEALTHY

NCT01928914 GSK DRUG 4. COMPLETED 1 26018

YEARS65

YEARSMALARIA, VIVAX

NCT01929070 HANMI DRUG 4. COMPLETED 1 1220

YEARS55

YEARSHEALTHY

NCT01929278 GSK DRUG 4. COMPLETED 1 3718

YEARS65

YEARSACNE VULGARIS

NCT01230060BAUSCH & LOMB

DEVICE 4. COMPLETED 3 12218

YEARSN/A CATARACT

NCT01928628 LG LIFE DRUG 4. COMPLETED 3 44920

YEARS75

YEARSHYPERTENSION

NCT01928888 BAYER DRUG 4. COMPLETED 4 47718

YEARS65

YEARSHEARTBURN

NCT01928992 FUJIFILM DEVICE 4. COMPLETED NA 10018

YEARSN/A BREAST CANCER

NCT00014131CALIFORNIA STEM CELL

BIOLOGICAL 7. TERMINATED 1 916

YEARSN/A KIDNEY CANCER

NCT00814593CALIFORNIA STEM CELL

BIOLOGICAL 7. TERMINATED 2 8018

YEARSN/A BRAIN TUMORS

New Studies, from Page 4

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

Page 6: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 6

NeW reSulTS

This table lists all industry-sponsored studies with results posted during the past week.

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT00595088 BIOCANCELL BIOLOGICAL 3. ONGOING 2 4718

YEARSN/A

SUPERFICIAL BLADDER CANCER

NCT00398086 CELGENE DRUG 4. COMPLETED 1 6718

YEARSN/A

PANCREATIC CANCER

NCT00565136AMERICAN MEDICAL

DEVICE 4. COMPLETED 1 2921

YEARSN/A

FECAL INCONTINENCE

NCT01595854BOEHRINGER INGELHEIM

DRUG 4. COMPLETED 1 3618

YEARS45

YEARSHEALTHY

NCT01653158 PFIZER DRUG 4. COMPLETED 1 4618

YEARSN/A

NON-HEMATOLOGIC MALIGNANCIES

NCT00615017 ASTRAZENECA DRUG 4. COMPLETED 2 7018

YEARSN/A SEVERE SEPSIS

NCT00642642 FIBROCELL BIOLOGICAL 4. COMPLETED 2 12218

YEARS65

YEARSACNE SCARRING

NCT00720434 PFIZER DRUG 4. COMPLETED 2 3518

YEARS65

YEARSHEPATITIS C

NCT01144624 ASTRAZENECA DRUG 4. COMPLETED 2 2020

YEARSN/A SEPTIC SHOCK

NCT00113607JOHNSON & JOHNSON

DRUG 4. COMPLETED 3 67218

YEARSN/A OVARIAN CANCER

NCT00660907 ASTRAZENECA DRUG 4. COMPLETED 3 81418

YEARSN/A TYPE 2 DIABETES

NCT00673231 ASTRAZENECA DRUG 4. COMPLETED 3 1,24018

YEARS80

YEARSTYPE 2 DIABETES

NCT00753922 MENTOR DEVICE 4. COMPLETED 3 1,00818

YEARSN/A BREAST REVISION

NCT01031680 ASTRAZENECA DRUG 4. COMPLETED 3 92245

YEARSN/A

INADEQUATE GLYCAEMIC CONTROL

NCT01042977 ASTRAZENECA DRUG 4. COMPLETED 3 96445

YEARSN/A

INADEQUATE GLYCAEMIC CONTROL

NCT01181895 GSK DRUG 4. COMPLETED 3 34812

YEARSN/A ASTHMA

NCT01230060BAUSCH & LOMB

DEVICE 4. COMPLETED 3 12218

YEARSN/A CATARACT

NCT01294423 ASTRAZENECA DRUG 4. COMPLETED 3 26120

YEARSN/A HIGH BLOOD SUGAR

NCT01607411 GSK DRUG 4. COMPLETED 3 5511

YEARS14

YEARSDENTAL CARIES

NCT00766831 JANSSEN DRUG 4. COMPLETED 4 19020

YEARSN/A CANCER PAIN

NCT00814658 JANSSEN DRUG 4. COMPLETED 4 2265

YEARSN/A DEMENTIA

NCT01213173 ASTRAZENECA DRUG 4. COMPLETED 4 25118

YEARS75

YEARSANGINA PECTORIS

(See New results, Page 7)

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

Page 7: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 7

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01635296HOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 4018

YEARSN/A

MYELOGENOUS LEUKEMIA, ACUTE

NCT01657942 INSIGHTEC DEVICE 2. RECRUITING 1 4055

YEARS75

YEARSPROSTATE CANCER

NCT01754844 ASTRAZENECA DRUG 2. RECRUITING 1 7218

YEARS55

YEARSCOPD

NCT01496742 GENENTECH DRUG 2. RECRUITING 2 26018

YEARSN/A

NON-SMALL CELL LUNG CANCER

NCT01685281 ALCOBRA DRUG 2. RECRUITING 2 3618

YEARS55

YEARSADHD

NCT01448057 NOVARTIS DRUG 2. RECRUITING 3 24418

YEARS65

YEARSSNEEZING

NCT01475643BAUSCH & LOMB

DRUG 2. RECRUITING 3 170 N/A11

YEARSCATARACT

NCT01544491 NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01663623 GSK BIOLOGICAL 2. RECRUITING 3 40018

YEARSN/A VASCULITIS

NCT00773513HOFFMANN-LA ROCHE

DRUG 2. RECRUITING 4 2,80018

YEARSN/A ANEMIA

NCT01429792HOFFMANN-LA ROCHE

DRUG 2. RECRUITING 4 20018

YEARSN/A

HEPATITIS C, CHRONIC

NCT01424475 GSK GENETIC 2. RECRUITING NA 4018

YEARSN/A

PARKINSON DISEASE

NCT01110486 ABBVIE DRUG 3. ONGOING 1 12018

YEARSN/A SOLID TUMORS

NCT01136733 EISAI DRUG 3. ONGOING 1 18018

YEARSN/A

METASTATIC RENAL CELL CARCINOMA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See New Study Status, Page 8)

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01843660 XIAN-JANSSEN DRUG 4. COMPLETED 4 1,05918

YEARS65

YEARSNECK PAIN

NCT01278485 MERCK DRUG 4. COMPLETED NA 72630

YEARSN/A

TYPE 2 DIABETES MELLITUS

NCT01422538 ULTHERA DEVICE 4. COMPLETED NA 3035

YEARS60

YEARSSKIN LAXITY

NCT00862082 PROACTAD DRUG 7. TERMINATED 1 1418

YEARSN/A

HEPATOCELLULAR CARCINOMA

NCT00929474 ST JUDE DEVICE 7. TERMINATED 4 1718

YEARSN/A HEART FAILURE

New results, from Page 6

NeW STudy STATuS

This table lists studies that reported updates in their status in the past week such as recruiting, ongoing or completed.

(Return to Page 1)

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 8

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01209130 GENENTECH DRUG 3. ONGOING 1 9218

YEARSN/A

CHRONIC LYMPHOCYTIC LEUKEMIA

NCT01446159 MEDIMMUNE DRUG 3. ONGOING 1 18718

YEARSN/A BREAST CANCER

NCT01457417 DEKKUN DRUG 3. ONGOING 1 3930

YEARSN/A

NON-SMALL CELL LUNG CANCER

NCT01598129ONCOS THERAPEUTICS

GENETIC 3. ONGOING 1 1218

YEARSN/A SOLID TUMOUR

NCT01680991HOFFMANN-LA ROCHE

DRUG 3. ONGOING 1 4818

YEARSN/A

LYMPHOMA, B-CELL

NCT00769470TRANSLATIONAL ONCOLOGY

BIOLOGICAL 3. ONGOING 2 14018

YEARS70

YEARSBREAST CANCER

NCT00936715 GILEAD DRUG 3. ONGOING 2 2418

YEARS75

YEARSCHRONIC HEPATITIS B

NCT01217632 FIBROGEN DRUG 3. ONGOING 2 22818

YEARS75

YEARSLIVER FIBROSIS

NCT01334567 GILEAD DRUG 3. ONGOING 2 3018

YEARS69

YEARSHEPATITIS B

NCT01414855 GENENTECH DRUG 3. ONGOING 2 10118

YEARSN/A

LYMPHOMA, B-CELL

NCT01442090 GENENTECH DRUG 3. ONGOING 2 8518

YEARSN/A

RENAL CELL CARCINOMA

NCT01576718 TEVA DRUG 3. ONGOING 2 62212

YEARSN/A ASTHMA

NCT01701232 BIOCAD BIOLOGICAL 3. ONGOING 2 9218

YEARS95

YEARSSPLENIC LYMPHOMA

NCT01754935 VERTEX DRUG 3. ONGOING 2 4018

YEARS65

YEARSRHEUMATOID ARTHRITIS

NCT01183780 ELI LILLY BIOLOGICAL 3. ONGOING 3 1,05018

YEARSN/A

COLORECTAL CANCER

NCT01345929 CUBIST DRUG 3. ONGOING 3 50018

YEARSN/A PYELONEPHRITIS

NCT01373580REVISION OPTICS

DEVICE 3. ONGOING 3 37335

YEARS65

YEARSPRESBYOPIA

NCT01445665 CUBIST DRUG 3. ONGOING 3 50018

YEARSN/A

INTRA-ABDOMI-NAL INFECTION

NCT01468233 ABBVIE BIOLOGICAL 3. ONGOING 3 30018

YEARSN/A

HIDRADENITIS SUPPURATIVA

NCT01471574 BMS DRUG 3. ONGOING 3 30018

YEARS70

YEARSHEPATITIS C, GENOTYPE 1

NCT01472185 GILEAD DRUG 3. ONGOING 3 42018

YEARS75

YEARS

TYPE 2 DIABETES MELLITUS

NCT01494987 GILEAD DRUG 3. ONGOING 3 42018

YEARS75

YEARS

TYPE 2 DIABETES MELLITUS

New Study Status, from Page 7

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See New Study Status, Page 9)(Return to Page 1)

Page 9: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 9

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01539512 GILEAD DRUG 3. ONGOING 3 16018

YEARSN/A

CHRONIC LYMPHOCYTIC LEUKEMIA

NCT01580228 MERCK DRUG 3. ONGOING 3 46618

YEARSN/A

CHRONIC LYMPHOCYTIC LEUKEMIA

NCT01591161BAUSCH & LOMB

DRUG 3. ONGOING 3 30018

YEARSN/A SURGERY

NCT01626222 NOVARTIS DRUG 3. ONGOING 3 30218

YEARSN/A

METASTATIC BREAST CANCER

NCT01674634 AUXILIUM BIOLOGICAL 3. ONGOING 3 60018

YEARSN/A

DUPUYTREN’S CONTRACTURE

NCT01674712 ABBOTT DRUG 3. ONGOING 3 57718

YEARS80

YEARSDYSLIPIDEMIA

NCT01691846HOFFMANN-LA ROCHE

DRUG 3. ONGOING 3 20018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT00658827 JANSSEN OTHER 3. ONGOING 4 370 N/A N/AINFLAMMATORY BOWEL DISEASE

NCT01231659 NOVARTIS DRUG 3. ONGOING 4 7318

YEARSN/A BREAST CANCER

NCT01503476 GIVEN IMAGING DEVICE 3. ONGOING 4 17018

YEARSN/A

GASTRO ESOPHAGEAL REFLUX DISEASE

NCT01477671 SANOFI 3. ONGOING NA 2,614 5 YEARS10

YEARS

DENGUE HEMORRHAGIC FEVER

NCT01483326HOFFMANN-LA ROCHE

3. ONGOING NA 21018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT00565136AMERICAN MEDICAL

DEVICE 4. COMPLETED 1 2921

YEARSN/A

FECAL INCONTINENCE

NCT00697346 MILLENNIUM DRUG 4. COMPLETED 1 5818

YEARSN/A NK LYMPHOMA

NCT01097590 IBD DEVICE 4. COMPLETED 1 2318

YEARS75

YEARSULCERATIVE COLITIS

NCT01166490SEATTLE GENETICS

DRUG 4. COMPLETED 1 5118

YEARSN/A

PANCREATIC NEOPLASMS

NCT01205737 TEVA BIOLOGICAL 4. COMPLETED 1 18618

YEARS80

YEARSDLBCL

NCT01291004 TEVA DRUG 4. COMPLETED 1 20618

YEARS35

YEARSORAL CONTRACEPTIVE

NCT01317797 TAKEDA DRUG 4. COMPLETED 1 2418

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01385566 MERCK BIOLOGICAL 4. COMPLETED 1 22350

YEARSN/A HERPES ZOSTER

NCT01454349 SOPHIRIS DRUG 4. COMPLETED 1 4050

YEARS80

YEARSPROSTATIC HYPERPLASIA

NCT01521455 HANMI DRUG 4. COMPLETED 1 5620

YEARS75

YEARSASTHMA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See New Study Status, Page 10)

New Study Status, from Page 8

(Return to Page 1)

Page 10: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 10

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01739647 ASTRAZENECA DRUG 4. COMPLETED 1 7218

YEARS80

YEARSHEALTHY

NCT01748552 ELI LILLY DRUG 4. COMPLETED 1 3621

YEARS65

YEARSDIABETES MELLITUS, TYPE 2

NCT00137969 GENENTECH DRUG 4. COMPLETED 2 25716

YEARS75

YEARSLUPUS ERYTHEMATOSUS

NCT00402168 BMS DRUG 4. COMPLETED 2 17118

YEARSN/A

RENAL TRANSPLANT

NCT00508404 AMGEN DRUG 4. COMPLETED 2 15418

YEARSN/A

METASTATIC COLORECTAL CANCER

NCT00948090 OTSUKA DRUG 4. COMPLETED 2 20718

YEARS65

YEARSLYMPHOMA

NCT01109264JIANGSU SIMCERE

DRUG 4. COMPLETED 2 14718

YEARS75

YEARS

CHRONIC LYMPHOCYTIC LEUKEMIA

NCT01146535 AMARILLO DRUG 4. COMPLETED 2 4020

YEARS65

YEARSINFLUENZA A VIRUS INFECTION

NCT01296711 UCB BIOLOGICAL 4. COMPLETED 2 19018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01310114 CELGENE BIOLOGICAL 4. COMPLETED 2 4418

YEARS80

YEARS

POSTERIOR CEREBRAL ARTERY STROKE

NCT01348152 TSUMURA DRUG 4. COMPLETED 2 5018

YEARS80

YEARSFUNCTIONAL CONSTIPATION

NCT01356160 GILEAD DRUG 4. COMPLETED 2 35118

YEARS70

YEARSHEPATITIS C, CHRONIC

NCT01491529 NOVARTIS DRUG 4. COMPLETED 2 15430

YEARS80

YEARSANTI-DYSKINESIA AGENTS

NCT01555151 NOVARTIS DRUG 4. COMPLETED 2 61612

YEARSN/A ASTHMA

NCT01684800 FERRING DRUG 4. COMPLETED 2 17820

YEARSN/A NOCTURIA

NCT01694498 FERRING DRUG 4. COMPLETED 2 18320

YEARSN/A NOCTURIA

NCT00299104 GENENTECH DRUG 4. COMPLETED 3 75518

YEARS80

YEARSRHEUMATOID ARTHRITIS

NCT00660907 ASTRAZENECA DRUG 4. COMPLETED 3 81418

YEARSN/A TYPE 2 DIABETES

NCT00753922 MENTOR DEVICE 4. COMPLETED 3 1,00818

YEARSN/A

BREAST REVISION

NCT00911326 NAVIDEA DRUG 4. COMPLETED 3 20018

YEARSN/A

HEAD/NECK CARCINOMA

NCT01202760 ELI LILLY DRUG 4. COMPLETED 3 1,00218

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01249664 BAYER BIOLOGICAL 4. COMPLETED 3 12218

YEARSN/A

MYOPIA, PATHOLOGICAL

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See New Study Status, Page 11)

New Study Status, from Page 9

(Return to Page 1)

Page 11: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 11

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01254019 GSK DRUG 4. COMPLETED 3 186 5 YEARS N/AMUSCULAR DYSTROPHIES

NCT01313624 GILEAD DRUG 4. COMPLETED 3 26618

YEARSN/A BRONCHIECTASIS

NCT01314716 GILEAD DRUG 4. COMPLETED 3 27418

YEARSN/A BRONCHIECTASIS

NCT01370642 MERCK DRUG 4. COMPLETED 3 29420

YEARS70

YEARSHEPATITIS C, CHRONIC

NCT01445951 MANNKIND DRUG 4. COMPLETED 3 51818

YEARSN/A

TYPE 1 DIABETES MELLITUS

NCT01451398 MANNKIND DRUG 4. COMPLETED 3 35318

YEARSN/A TYPE 2 DIABETES

NCT01459367 TAKEDA DRUG 4. COMPLETED 3 60720

YEARSN/A

EROSIVE ESOPHAGITIS

NCT01470053 HANLIM DRUG 4. COMPLETED 3 34712

YEARSN/A

PERENNIAL ALLERGIC RHINITIS

NCT01474772 PFIZER DRUG 4. COMPLETED 3 28818

YEARSN/A

DIABETIC PERIPHERAL NEUROPATHY

NCT01620489 NOVO NORDISK DRUG 4. COMPLETED 3 27918

YEARS80

YEARS

DIABETES MELLITUS, TYPE 2

NCT01636401 DAEWOONG DRUG 4. COMPLETED 3 MISS-

ING 40

YEARSN/A COPD

NCT01680341 NOVO NORDISK DRUG 4. COMPLETED 3 27218

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01697956 TEVA DRUG 4. COMPLETED 3 99 6 YEARS11

YEARSALLERGIC RHINITIS

NCT01789606 PFIZER DRUG 4. COMPLETED 3 71212

YEARSN/A ANALGESIA

NCT01308619 GALDERMA DRUG 4. COMPLETED 4 17018

YEARS70

YEARSROSACEA

NCT01322633 PFIZER OTHER 4. COMPLETED 4 61,86418

YEARSN/A ESOPHAGITIS

NCT01727791 PFIZER DRUG 4. COMPLETED 4 1018

YEARS45

YEARS

HEALTHY LACTATING WOMEN

NCT00730548 MEDTRONIC BEHAVIORAL 4. COMPLETED NA 18018

YEARSN/A

CARDIAC DESYNCHRONIZA-TION

NCT01353274BOEHRINGER INGELHEIM

DRUG 4. COMPLETED NA 1,157 N/A N/A HYPERTENSION

NCT01395862 GSK DRUG 4. COMPLETED NA 1,001 N/A N/ARESPIRATORY DISORDERS

NCT01715155 ASTRAZENECA 4. COMPLETED NA 17118

YEARSN/A

METASTATIC BREAST CANCER

New Study Status, from Page 10

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

Page 12: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 12

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01927224 ARGENTINA BAYER DRUG 1. PLANNING 1 3618

YEARS45

YEARSCHAGAS DIS-EASE

NCT01544491 ARGENTINA NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANS-PLANT

NCT01712516 ARGENTINA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01768572 ARGENTINA SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01875003 ARGENTINAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01846611 AUSTRALIA JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01843387 AUSTRALIA MESO BIOLOGICAL 2. RECRUITING 1 3060

YEARS85

YEARSTYPE 2 DIABETES

NCT01785602 AUSTRALIA NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMA-TITIS

NCT01835535 AUSTRALIA CARDIOSONIC DEVICE 2. RECRUITING 2 8018

YEARS80

YEARSHYPERTENSION

NCT01764997 AUSTRALIA SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01928615 AUSTRIAHOFFMANN-LA ROCHE

DRUG 1. PLANNING 2 5018

YEARSN/A BREAST CANCER

NCT01711619 AUSTRIA MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01838616 AUSTRIA GRENENTHAL DRUG 2. RECRUITING 4 24018

YEARSN/A

NEUROPATHIC PAIN

NCT01928901 BELGIUM BIONORICA DRUG 1. PLANNING 2 5625

YEARS40

YEARSCURRENT SMOK-ERS

NCT01785602 BELGIUM NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMA-TITIS

NCT01544491 BELGIUM NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANS-PLANT

NCT01785875 BELGIUM AMGEN DRUG 2. RECRUITING 3 1,00018

YEARSN/A

HYPERPARATHY-ROIDISM

NCT01831765 BELGIUMNOVO NOR-DISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MEL-LITUS, TYPE 1

NCT01926912 BELGIUM JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01715909 BRAZILHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01544491 BRAZIL NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANS-PLANT

NCT01782326 BRAZIL NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01875003 BRAZILHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01926782 BULGARIA REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

STudieS opeNiNG A firST SiTe iN A NeW CouNTry

This table lists studies that launched a site in a country for the first time in the past week.

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 13)(Return to Page 1)

Page 13: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 13

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01928979 BULGARIA BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLA-TION

NCT01785602 BULGARIA NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMA-TITIS

NCT01819129 CANADANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01926782 CANADA REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01296555 CANADA GENENTECH DRUG 2. RECRUITING 1 21918

YEARSN/A SOLID CANCERS

NCT01822613 CANADA NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01926444 CANADA GICARE DRUG 2. RECRUITING 2 24040

YEARS70

YEARSCOLONIC DIS-EASES

NCT01868061 CANADAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01875003 CANADAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01927757 CANADA AMGEN BIOLOGICAL 2. RECRUITING 4 25018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01927679 CANADA INNOVADERM DRUG 2. RECRUITING NA 1018

YEARSN/A

PIGMENTATION FROM VISIBLE LIGHT

NCT01928953 CANADA ASTRAZENECA 2. RECRUITING NA 90018

YEARS85

YEARSOPIOID INDUCED CONSTIPATION

NCT01929044 CHINABOEHRINGER INGELHEIM

DRUG 1. PLANNING 3 29618

YEARS70

YEARSINTESTINAL DIS-EASES

NCT01929096 CHINAJIANGSU SIMCERE

DRUG 2. RECRUITING 2 40035

YEARS75

YEARSACUTE ISCHEMIC STROKE

NCT01836471 COLOMBIA NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01663402 COLOMBIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORO-NARY SYN-DROME

NCT01875003 COLOMBIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01926951 CZECH REP KONA DEVICE 1. PLANNING NA 2018

YEARSN/A HYPERTENSION

NCT01764997 CZECH REP SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01785875 CZECH REP AMGEN DRUG 2. RECRUITING 3 1,00018

YEARSN/A

HYPERPARATHY-ROIDISM

NCT01875003 CZECH REPHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01902134 CZECH REP MENARINI DRUG 2. RECRUITING 3 60018

YEARS80

YEARSACUTE PAIN

NCT01927900 DENMARK GLYCOMDIETARY SUP.

1. PLANNING NA 10018

YEARS60

YEARSGASTROINTESTI-NAL SYMPTOMS

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 14)

Studies opening a first Site in a New Country, from Page 12

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Page 14: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 14

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01798706 DENMARK SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A TYPE 2 DIABETES

NCT01926912 DENMARK JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01928875 FINLANDGE HEALTHCARE

DEVICE 1. PLANNING NA 50018

YEARS80

YEARSSURGICAL INTERVENTION

NCT01926496 FRANCE LEO DRUG 1. PLANNING 4 48018

YEARSN/A

ACTINIC KERATOSIS

NCT01928979 FRANCE BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLATION

NCT01794520 FRANCE ABBVIE DRUG 2. RECRUITING 1 3018

YEARSN/A

MULTIPLE MYELOMA

NCT01822613 FRANCE NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01544491 FRANCE NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01875003 FRANCEHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01929109 GERMANY ELI LILLY DRUG 1. PLANNING 1 6018

YEARS85

YEARSRENAL INSUFFICIENCY

NCT01926847 GERMANY BAYER DRUG 1. PLANNING 2 2018

YEARS70

YEARSRAYNAUD DISEASE

NCT01926496 GERMANY LEO DRUG 1. PLANNING 4 48018

YEARSN/A

ACTINIC KERATOSIS

NCT01928875 GERMANYGE HEALTHCARE

DEVICE 1. PLANNING NA 50018

YEARS80

YEARSSURGICAL INTERVENTION

NCT01928979 GERMANY BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLATION

NCT01336634 GERMANY GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01377480 GERMANY MERCK DRUG 2. RECRUITING 2 16018

YEARS50

YEARSCHAGAS DISEASE

NCT01696045 GERMANY BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01785602 GERMANY NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMATITIS

NCT01836471 GERMANY NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01928433 GERMANY MERLION DRUG 2. RECRUITING 2 25818

YEARSN/A

ACUTE PYELONEPHRITIS

NCT01831765 GERMANYNOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

NCT01875003 GERMANYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01711619 GERMANY MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01926912 GERMANY JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 15)

Studies opening a first Site in a New Country, from Page 13

(Return to Page 1)

Page 15: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 15

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01926873 GERMANYHOFFMANN-LA ROCHE

2. RECRUITING NA 24018

YEARS65

YEARSHEALTHY VOLUNTEER

NCT01926912 GREECE JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01822613 HONG KONG NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01782326 HONG KONG NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01926782 HUNGARY REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01928875 HUNGARYGE HEALTHCARE

DEVICE 1. PLANNING NA 50018

YEARS80

YEARSSURGICAL INTERVENTION

NCT01544491 HUNGARY NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01768702 HUNGARY CARDIO3 BIOLOGICAL 2. RECRUITING 3 24018

YEARS80

YEARSHEART FAILURE

NCT01875003 HUNGARYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01836471 INDIA NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01445678 INDIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA-ABDOMI-NAL INFECTION

NCT01926782 ISRAEL REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01445678 ISRAEL CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA-ABDOMI-NAL INFECTION

NCT01764997 ISRAEL SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01768702 ISRAEL CARDIO3 BIOLOGICAL 2. RECRUITING 3 24018

YEARS80

YEARSHEART FAILURE

NCT01776424 ISRAEL BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

PREVENTION & CONTROL

NCT01875003 ISRAELHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01711619 ISRAEL MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01926912 ISRAEL JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01336634 ITALY GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01544491 ITALY NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01875003 ITALYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01854047 JAPAN SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01928940 JAPAN GSK DRUG 2. RECRUITING 2 1220

YEARSN/A SOLID TUMOURS

NCT01261325 JAPAN UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 16)

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Page 16: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 16

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01782326 JAPAN NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01927263 JAPAN NICHI-IKO BIOLOGICAL 2. RECRUITING 3 23020

YEARS75

YEARSRHEUMATOID ARTHRITIS

NCT01927861 JAPANNOVO NORDISK

DRUG 2. RECRUITING 3 483

YEARS11

YEARSNOONAN SYNDROME

NCT01928563 KOREA, SOUTH DONG-A DRUG 1. PLANNING 1 2420

YEARS45

YEARSHEALTHY MALE SUBJECTS

NCT01822613 KOREA, SOUTH NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01929213 KOREA, SOUTH DONG-A DRUG 2. RECRUITING 1 3020

YEARS45

YEARSHEALTHY VOLUNTEERS

NCT01836471 KOREA, SOUTH NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01761266 KOREA, SOUTH EISAI DRUG 2. RECRUITING 3 94018

YEARSN/A

HEPATOCELLU-LAR CARCINOMA

NCT01492504 KOREA, SOUTH BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01445678 LATVIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA-ABDOMI-NAL INFECTION

NCT01696266 LEBANONNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01830985 LITHUANIA VERTEX DRUG 2. RECRUITING 2 4018

YEARS65

YEARSRHEUMATOID ARTHRITIS

NCT01261325 LITHUANIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01904149 LITHUANIA MENARINI DRUG 2. RECRUITING 3 60018

YEARS75

YEARSACUTE PAIN

NCT01846273 MALAYSIA NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01696266 MALAYSIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01872689 MEXICOHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01600092 MEXICO MERCK BIOLOGICAL 2. RECRUITING 3 9246

WEEKS12

WEEKSROTAVIRUS GAS-TROENTERITIS

NCT01712516 MEXICO NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01875003 MEXICOHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01903824 NETHERLANDS TEVA DRUG 1. PLANNING 1 4018

YEARS50

YEARSCOGNITIVE IMPAIRMENT

NCT01928875 NETHERLANDSGE HEALTHCARE

DEVICE 1. PLANNING NA 50018

YEARS80

YEARSSURGICAL INTERVENTION

NCT01362244 NETHERLANDS GSK DRUG 2. RECRUITING 2 11018

YEARS70

YEARSPOLYPS, NASAL

NCT01785602 NETHERLANDS NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMATITIS

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 17)

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Page 17: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 17

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01846611 NEW ZEALAND JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01926951 NEW ZEALAND KONA DEVICE 1. PLANNING NA 2018

YEARSN/A HYPERTENSION

NCT01854047 NEW ZEALAND SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01764997 NEW ZEALAND SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01927068 NEW ZEALAND COVIDIEN DEVICE 2. RECRUITING NA 50018

YEARSN/A

PERIPHERAL ARTERIAL DISEASE

NCT01926782 NORWAY REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01544491 NORWAY NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01798706 NORWAY SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A TYPE 2 DIABETES

NCT01875003 PERUHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01727141 PHILIPPINES NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01782326 PHILIPPINES NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01926782 POLAND REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01928979 POLAND BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLATION

NCT01836471 POLAND NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01544491 POLAND NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01610414 POLAND GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A HERPES ZOSTER

NCT01831765 POLANDNOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

NCT01875003 POLANDHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01926873 POLANDHOFFMANN-LA ROCHE

2. RECRUITING NA 24018

YEARS65

YEARSHEALTHY VOLUNTEER

NCT01785602 ROMANIA NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMATITIS

NCT01836471 ROMANIA NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01819129 RUSSIANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01846611 RUSSIA JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 18)

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Page 18: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 18

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01928979 RUSSIA BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLATION

NCT01782326 RUSSIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01875003 RUSSIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01410890 RUSSIA GENZYME BIOLOGICAL 2. RECRUITING 4 208

YEARS18

YEARSACID MALTASE DEFICIENCY

NCT01926912 RUSSIA JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01696266 RUSSIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01926873 RUSSIAHOFFMANN-LA ROCHE

2. RECRUITING NA 24018

YEARS65

YEARSHEALTHY VOLUNTEER

NCT01445678 SERBIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA-ABDOMI-NAL INFECTION

NCT01822613 SINGAPORE NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01761266 SINGAPORE EISAI DRUG 2. RECRUITING 3 94018

YEARSN/A

HEPATOCELLU-LAR CARCINOMA

NCT01819129 SLOVAKIANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01926782 SLOVAKIA REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01875003 SLOVAKIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01926782 SOUTH AFRICA REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01785602 SOUTH AFRICA NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMATITIS

NCT01830985 SOUTH AFRICA VERTEX DRUG 2. RECRUITING 2 4018

YEARS65

YEARSRHEUMATOID ARTHRITIS

NCT01836471 SOUTH AFRICA NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01875003 SOUTH AFRICAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01927341 SPAIN NOVARTIS DRUG 1. PLANNING 1 9018

YEARSN/A

COLORECTAL CANCER

NCT01786668 SPAIN PFIZER DRUG 2. RECRUITING 2 20018

YEARSN/A

ANKYLOSING SPONDYLITIS

NCT01764997 SPAIN SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01838616 SPAIN GRENENTHAL DRUG 2. RECRUITING 4 24018

YEARSN/A

NEUROPATHIC PAIN

NCT01926912 SPAIN JANSSEN DRUG 2. RECRUITING 4 45018

YEARSN/A SCHIZOPHRENIA

NCT01544491 SWEDEN NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 19)

Studies opening a first Site in a New Country, from Page 17

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Page 19: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 19

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01785875 SWEDEN AMGEN DRUG 2. RECRUITING 3 1,00018

YEARSN/A

HYPERPARATHY-ROIDISM

NCT00685750 SWEDEN GSK PROCEDURE 2. RECRUITING NA 16018

YEARSN/A

LUNG CANCER, NON-SMALL CELL

NCT01822613 TAIWAN NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01897038 TAIWANHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 5418

YEARSN/A LIVER CANCER

NCT01336634 TAIWAN GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01610414 TAIWAN GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A HERPES ZOSTER

NCT01782326 TAIWAN NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01492504 TAIWAN BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01386528 THAILANDNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01855997 THAILANDHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01928979 TURKEY BAYER OTHER 1. PLANNING NA 15018

YEARSN/A

ATRIAL FIBRILLATION

NCT01571284 TURKEY SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01875003 UKRAINEHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01410890 UKRAINE GENZYME BIOLOGICAL 2. RECRUITING 4 208

YEARS18

YEARSACID MALTASE DEFICIENCY

NCT01929109 UK ELI LILLY DRUG 1. PLANNING 1 6018

YEARS85

YEARSRENAL INSUFFICIENCY

NCT01926782 UK REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01926496 UK LEO DRUG 1. PLANNING 4 48018

YEARSN/A

ACTINIC KERATOSIS

NCT01715909 UKHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01822613 UK NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01928147 UK PRESIDIO DRUG 2. RECRUITING 1 14418

YEARS65

YEARSHEPATITIS C, CHRONIC

NCT01436487 UK ATHERSYS BIOLOGICAL 2. RECRUITING 2 14018

YEARS83

YEARSISCHEMIC STROKE

NCT01480479 UK CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01544491 UK NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01768572 UK SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 20)

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 20

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01831765 UKNOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

NCT01927341 USA NOVARTIS DRUG 1. PLANNING 1 9018

YEARSN/A

COLORECTAL CANCER

NCT01928459 USA NOVARTIS DRUG 1. PLANNING 1 5518

YEARSN/A SOLID TUMORS

NCT01928472 USA NOVARTIS BIOLOGICAL 1. PLANNING 1 40018

YEARS64

YEARSH7N9 INFLUENZA

NCT01927198 USA ARDEA DRUG 1. PLANNING 2 16018

YEARS70

YEARSGOUT

NCT01928381 USA ASTRAZENECA DRUG 1. PLANNING 2 6518

YEARS75

YEARSDIABETIC NEUROPATHY

NCT01819129 USANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01926782 USA REGENERON DRUG 1. PLANNING 3 70018

YEARSN/A

HYPERCHOLES-TEROLEMIA

NCT01927055 USA CHELSEA DRUG 1. PLANNING 3 45018

YEARSN/A

DOPAMINE DEFICIENCY

NCT01927575 USA FUJIFILM DEVICE 1. PLANNING NA 3018

YEARSN/A HIP INJURY

NCT01657942 USA INSIGHTEC DEVICE 2. RECRUITING 1 4055

YEARS75

YEARSPROSTATE CANCER

NCT01926587 USA ONCONOVA DRUG 2. RECRUITING 1 4018

YEARSN/A

CHRONIC MY-ELOMONOCYTIC LEUKEMIA

NCT01928368 USA AMGEN DRUG 2. RECRUITING 1 9618

YEARS45

YEARSASTHMA

NCT01929226 USA ELUSYS BIOLOGICAL 2. RECRUITING 1 28018

YEARSN/A

INHALATIONAL ANTHRAX

NCT01836471 USA NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01853878 USA GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A

NON-SMALL CELL LUNG CANCER

NCT01917383 USA INOTEK DRUG 2. RECRUITING 2 11018

YEARSN/A GLAUCOMA

NCT01926444 USA GICARE DRUG 2. RECRUITING 2 24040

YEARS70

YEARSCOLONIC DISEASES

NCT01761266 USA EISAI DRUG 2. RECRUITING 3 94018

YEARSN/A

HEPATOCELLU-LAR CARCINOMA

NCT01769170 USA CHIMERIX DRUG 2. RECRUITING 3 45018

YEARS89

YEARSBK VIRUS (BKV)

NCT01785875 USA AMGEN DRUG 2. RECRUITING 3 1,00018

YEARSN/A

HYPERPARATHY-ROIDISM

NCT01831765 USANOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening a first Site in a New Country, Page 21)

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 21

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01862640 USA OTSUKA DRUG 2. RECRUITING 3 56055

YEARS90

YEARS

NERVOUS SYSTEM DISEASES

NCT01928537 USA ONCONOVA DRUG 2. RECRUITING 3 9018

YEARSN/A CYTOPENIA

NCT01929031 USABOEHRINGER INGELHEIM

DRUG 2. RECRUITING 3 56018

YEARS55

YEARSTOOTH DISEASES

NCT01927757 USA AMGEN BIOLOGICAL 2. RECRUITING 4 25018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01883063 USA SONOMA DEVICE 2. RECRUITING NA 12065

YEARSN/A

DISTAL RADIUS FRACTURE

NCT01923285 USASPINAL MODULATION

DEVICE 2. RECRUITING NA 15222

YEARS75

YEARSCHRONIC LOWER LIMB PAIN

NCT01926873 USAHOFFMANN-LA ROCHE

2. RECRUITING NA 24018

YEARS65

YEARSHEALTHY VOLUNTEER

NCT01927211 USA ARGENTUM DEVICE 2. RECRUITING NA 66018

YEARSN/A

POST-OPERATIVE PAIN

NCT01928953 USA ASTRAZENECA 2. RECRUITING NA 90018

YEARS85

YEARSOPIOID INDUCED CONSTIPATION

NCT01929369 USA VOLCANO 2. RECRUITING NA 10018

YEARS85

YEARSTHROMBOSED AV GRAFTS

NCT01727141 VIETNAM NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

Studies opening a first Site in a New Country, from Page 20

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 22)

STudieS opeNiNG AddiTioNAl SiTeS iN A CouNTry

This table lists studies that launched additional sites in a country in the past week.

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01377480 ARGENTINA MERCK DRUG 2. RECRUITING 2 16018

YEARS50

YEARSCHAGAS DISEASE

NCT01445678 ARGENTINA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01663402 ARGENTINA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01492504 ARGENTINA BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01696266 ARGENTINANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01696045 AUSTRALIA BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01854047 AUSTRALIA SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01480479 AUSTRALIA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 22

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01610414 AUSTRALIA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 AUSTRALIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01798706 AUSTRALIA SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01868061 AUSTRALIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01492504 AUSTRALIA BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01785602 AUSTRIA NOVARTIS DRUG 2. RECRUITING 2 9218

YEARS65

YEARSATOPIC DERMATITIS

NCT01261325 AUSTRIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 AUSTRIANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01480479 AUSTRIA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01663402 AUSTRIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 AUSTRIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01696266 AUSTRIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01822613 BELGIUM NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01362244 BELGIUM GSK DRUG 2. RECRUITING 2 11018

YEARS70

YEARSPOLYPS, NASAL

NCT01696045 BELGIUM BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01836471 BELGIUM NOVARTIS DRUG 2. RECRUITING 2 33618

YEARSN/A ASTHMA

NCT01261325 BELGIUM UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01571284 BELGIUM SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01610414 BELGIUM GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 BELGIUM SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 BELGIUM SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01768702 BELGIUM CARDIO3 BIOLOGICAL 2. RECRUITING 3 24018

YEARS80

YEARSHEART FAILURE

NCT01782326 BELGIUM NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 23

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01868061 BELGIUMHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01711619 BELGIUM MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01855997 BELGIUMHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01261325 BRAZIL UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01480479 BRAZIL CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01571284 BRAZIL SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01663402 BRAZIL SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01386528 BULGARIANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01445678 BULGARIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01663402 BULGARIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 BULGARIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01868061 BULGARIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01696266 BULGARIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01855997 BULGARIAHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01715909 CANADAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01872689 CANADAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01261325 CANADA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01480479 CANADA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01571284 CANADA SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 CANADA MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 CANADA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 CANADA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTECORONARY SYNDROME

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 24

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01727141 CANADA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01776424 CANADA BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01782326 CANADA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01798706 CANADA SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01492504 CANADA BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01696266 CANADANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01377480 CHILE MERCK DRUG 2. RECRUITING 2 16018

YEARS50

YEARSCHAGAS DISEASE

NCT01445678 CHILE CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01571284 CHILE SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01663402 CHILE SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01377480 COLOMBIA MERCK DRUG 2. RECRUITING 2 16018

YEARS50

YEARSCHAGAS DISEASE

NCT01480479 COLOMBIA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01712516 COLOMBIA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01782326 COLOMBIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01819129 CROATIANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01445678 CROATIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01782326 CROATIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01696266 CROATIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01261325 CZECH REP UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01480479 CZECH REP CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01600092 CZECH REP MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 CZECH REP GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 25

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01663402 CZECH REP SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 CZECH REP SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 CZECH REP NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01831765 CZECH REPNOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

NCT01696266 CZECH REPNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01571284 DENMARK SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 DENMARK MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01663402 DENMARK SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 DENMARK NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01492504 DENMARK BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01696266 DENMARKNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01712516 EGYPT NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01782326 EGYPT NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01830985 ESTONIA VERTEX DRUG 2. RECRUITING 2 4018

YEARS65

YEARSRHEUMATOID ARTHRITIS

NCT01853878 ESTONIA GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

NCT01261325 ESTONIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01445678 ESTONIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01610414 ESTONIA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 ESTONIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 ESTONIA SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 ESTONIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01715909 FINLANDHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01261325 FINLAND UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01571284 FINLAND SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 FINLAND MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 FINLAND GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 FINLAND SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01764997 FINLAND SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01768572 FINLAND SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 FINLAND NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01696266 FINLANDNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01336634 FRANCE GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01696045 FRANCE BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01853878 FRANCE GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

NCT01261325 FRANCE UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 FRANCENOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01610414 FRANCE GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 FRANCE SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01712516 FRANCE NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01764997 FRANCE SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 FRANCE NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT00685750 FRANCE GSK PROCEDURE 2. RECRUITING NA 16018

YEARSN/A LUNG CANCER

NCT01492504 FRANCE BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01855997 FRANCEHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01715909 GERMANYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01872689 GERMANYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01261325 GERMANY UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 GERMANYNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01445678 GERMANY CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01544491 GERMANY NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01571284 GERMANY SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01610414 GERMANY GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 GERMANY SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 GERMANY NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01798706 GERMANY SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01868061 GERMANYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01410890 GERMANY GENZYME BIOLOGICAL 2. RECRUITING 4 20 8 YEARS18

YEARSACID MALTASE DEFICIENCY

NCT01838616 GERMANY GRENENTHAL DRUG 2. RECRUITING 4 24018

YEARSN/A

NEUROPATHIC PAIN

NCT00685750 GERMANY GSK PROCEDURE 2. RECRUITING NA 16018

YEARSN/A LUNG CANCER

NCT01492504 GERMANY BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01855997 GERMANYHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01386528 GREECENOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01480479 GREECE CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01782326 GREECE NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01712516 GUATEMALA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01782326 GUATEMALA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01897038 HONG KONGHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 5418

YEARSN/A LIVER CANCER

NCT01261325 HONG KONG UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01610414 HONG KONG GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 28

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01663402 HONG KONG SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01846273 HONG KONG NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01261325 HUNGARY UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01445678 HUNGARY CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01480479 HUNGARY CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01663402 HUNGARY SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01712516 HUNGARY NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01768572 HUNGARY SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 HUNGARY NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01831765 HUNGARYNOVO NORDISK

DRUG 2. RECRUITING 3 1,09518

YEARSN/A

DIABETES MELLITUS, TYPE 1

NCT01868061 HUNGARYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01902134 HUNGARY MENARINI DRUG 2. RECRUITING 3 60018

YEARS80

YEARSACUTE PAIN

NCT01904149 HUNGARY MENARINI DRUG 2. RECRUITING 3 60018

YEARS75

YEARSACUTE PAIN

NCT01696266 HUNGARYNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01782326 ICELAND NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01261325 INDIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01480479 INDIA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01782326 INDIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01410890 INDIA GENZYME BIOLOGICAL 2. RECRUITING 4 20 8 YEARS18

YEARSACID MALTASE DEFICIENCY

NCT01696266 INDIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01571284 IRELAND SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01776424 IRELAND BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01492504 IRELAND BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 29

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01819129 ISRAELNOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01846611 ISRAEL JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01715909 ISRAELHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01571284 ISRAEL SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 ISRAEL MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 ISRAEL GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 ISRAEL SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 ISRAEL SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01868061 ISRAELHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01696266 ISRAELNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01715909 ITALYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01854047 ITALY SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01872689 ITALYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01261325 ITALY UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 ITALYNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01571284 ITALY SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01610414 ITALY GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 ITALY SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 ITALY SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01776424 ITALY BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01782326 ITALY NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01868061 ITALYHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 30

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT00685750 ITALY GSK PROCEDURE 2. RECRUITING NA 16018

YEARSN/A LUNG CANCER

NCT01492504 ITALY BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01853878 JAPAN GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

NCT01386528 JAPANNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01610414 JAPAN GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01761266 JAPAN EISAI DRUG 2. RECRUITING 3 94018

YEARSN/A

HEPATOCELLU-LAR CARCI-NOMA

NCT01776424 JAPAN BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01868061 JAPANHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01846273 JAPAN NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01492504 JAPAN BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01336634 KOREA, SOUTH GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01853878 KOREA, SOUTH GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

NCT01261325 KOREA, SOUTH UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01445678 KOREA, SOUTH CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01610414 KOREA, SOUTH GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 KOREA, SOUTH SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 KOREA, SOUTH NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01846273 KOREA, SOUTH NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01855997 KOREA, SOUTHHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01261325 LATVIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01663402 LATVIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 LATVIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01902134 LATVIA MENARINI DRUG 2. RECRUITING 3 60018

YEARS80

YEARSACUTE PAIN

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 31)

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 31

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01904149 LATVIA MENARINI DRUG 2. RECRUITING 3 60018

YEARS75

YEARSACUTE PAIN

NCT01571284 LEBANON SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01445678 LITHUANIA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01663402 LITHUANIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 LITHUANIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01386528 MACEDONIANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01610414 MALAYSIA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 MALAYSIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01377480 MEXICO MERCK DRUG 2. RECRUITING 2 16018

YEARS50

YEARSCHAGAS DISEASE

NCT01696045 MEXICO BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01261325 MEXICO UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01480479 MEXICO CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01663402 MEXICO SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01764997 MEXICO SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01768572 MEXICO SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01492504 MEXICO BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01696266 MEXICONOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01445678 MOLDOVA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01336634 NETHERLANDS GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01261325 NETHERLANDS UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 NETHERLANDSNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01571284 NETHERLANDS SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 32)

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 32

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 33)

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01663402 NETHERLANDS SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 NETHERLANDS SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01776424 NETHERLANDS BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01782326 NETHERLANDS NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01696266 NETHERLANDSNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01480479 NEW ZEALAND CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01610414 NEW ZEALAND GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 NEW ZEALAND SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01868061 NEW ZEALANDHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01855997 NEW ZEALANDHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01336634 NORWAY GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01571284 NORWAY SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01663402 NORWAY SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 NORWAY SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 NORWAY NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01610414 PANAMA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01712516 PANAMA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01480479 PERU CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01663402 PERU SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01868061 PERUHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01663402 PHILIPPINES SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01715909 POLANDHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 33

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 34)

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01261325 POLAND UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01445678 POLAND CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01480479 POLAND CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01600092 POLAND MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01663402 POLAND SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01727141 POLAND NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01768572 POLAND SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 POLAND NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01868061 POLANDHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01904149 POLAND MENARINI DRUG 2. RECRUITING 3 60018

YEARS75

YEARSACUTE PAIN

NCT01696266 POLANDNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01855997 POLANDHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01663402 PORTUGAL SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 PORTUGAL NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01386528 ROMANIANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01663402 ROMANIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01727141 ROMANIA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01768572 ROMANIA SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 ROMANIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01696266 ROMANIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MELLITUS, TYPE 2

NCT01855997 ROMANIAHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01853878 RUSSIA GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 34

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 35)

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01261325 RUSSIA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01571284 RUSSIA SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01610414 RUSSIA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 RUSSIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 RUSSIA SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01868061 RUSSIAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01819129 SERBIANOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01768702 SERBIA CARDIO3 BIOLOGICAL 2. RECRUITING 3 24018

YEARS80

YEARSHEART FAILURE

NCT01696266 SERBIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01897038 SINGAPOREHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 5418

YEARSN/A LIVER CANCER

NCT01663402 SINGAPORE SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01846273 SINGAPORE NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01663402 SLOVAKIA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01712516 SLOVAKIA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01782326 SLOVAKIA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01904149 SLOVAKIA MENARINI DRUG 2. RECRUITING 3 60018

YEARS75

YEARSACUTE PAIN

NCT01696266 SLOVAKIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01712516 SLOVENIA NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

NCT01696266 SLOVENIANOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01846611 SOUTH AFRICA JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01715909 SOUTH AFRICAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01386528 SOUTH AFRICANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01610414 SOUTH AFRICA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 35

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 36)

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01663402 SOUTH AFRICA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTECORONARY SYNDROME

NCT01782326 SOUTH AFRICA NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01868061 SOUTH AFRICAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01296555 SPAIN GENENTECH DRUG 2. RECRUITING 1 21918

YEARSN/A

SOLIDCANCERS

NCT01715909 SPAINHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01822613 SPAIN NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01336634 SPAIN GSK DRUG 2. RECRUITING 2 60 18 YEARS N/A CANCER

NCT01854047 SPAIN SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01872689 SPAINHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01261325 SPAIN UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 SPAINNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01571284 SPAIN SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 SPAIN MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 SPAIN GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 SPAIN SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01727141 SPAIN NOVARTIS DRUG 2. RECRUITING 3 1,000 40 YEARS N/A COPD

NCT01768572 SPAIN SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01782326 SPAIN NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01798706 SPAIN SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01868061 SPAINHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01492504 SPAIN BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01261325 SWEDEN UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01571284 SWEDEN SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 SWEDEN MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

Studies opening Additional Sites in a Country, from Page 34

(Return to Page 1)

Page 36: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 36

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01663402 SWEDEN SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01768572 SWEDEN SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01776424 SWEDEN BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01782326 SWEDEN NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01798706 SWEDEN SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01492504 SWEDEN BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01696266 SWEDENNOVO NORDISK

OTHER 2. RECRUITING NA 6,30018

YEARSN/A

DIABETE MEL-LITUS, TYPE 2

NCT01663402 SWITZERLAND SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01711619 SWITZERLAND MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01261325 TAIWAN UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 TAIWANNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01480479 TAIWAN CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01663402 TAIWAN SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01846273 TAIWAN NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01480479 THAILAND CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01571284 THAILAND SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01782326 THAILAND NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01846273 THAILAND NOVARTIS DRUG 2. RECRUITING 4 32018

YEARSN/A

MACULAR DEGENERATION

NCT01386528 TURKEYNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01610414 TURKEY GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01782326 TURKEY NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01663402 UKRAINE SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01727141 UKRAINE NOVARTIS DRUG 2. RECRUITING 3 1,00040

YEARSN/A COPD

Studies opening Additional Sites in a Country, from Page 35

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 37)(Return to Page 1)

Page 37: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 37

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01819129 UKNOVO NORDISK

DRUG 1. PLANNING 3 67618

YEARSN/A

DIABETES MEL-LITUS, TYPE 2

NCT01846611 UK JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01336634 UK GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

NCT01362244 UK GSK DRUG 2. RECRUITING 2 11018

YEARS70

YEARSPOLYPS, NASAL

NCT01696045 UK BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01853878 UK GSK BIOLOGICAL 2. RECRUITING 2 22018

YEARSN/A LUNG CANCER

NCT01261325 UK UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 UKNOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01571284 UK SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01610414 UK GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 UK SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01782326 UK NOVARTIS DRUG 2. RECRUITING 3 3,332 N/A N/A COPD

NCT01798706 UK SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01711619 UK MEDTRONIC DEVICE 2. RECRUITING 4 20018

YEARSN/A

FAILED BACK SURGERY

NCT01492504 UK BMS DRUG 2. RECRUITING NA 99018

YEARSN/A HEPATITIS C

NCT01855997 UKHOFFMANN-LA ROCHE

2. RECRUITING NA 1,20018

YEARSN/A

HEPATITIS B, CHRONIC

NCT01846611 USA JANSSEN DRUG 1. PLANNING 3 67018

YEARSN/A

FALLOPIAN TUBE NEOPLASMS

NCT01296555 USA GENENTECH DRUG 2. RECRUITING 1 21918

YEARSN/A

SOLID CANCERS

NCT01715909 USAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 20 N/A12

YEARSINFLUENZA

NCT01794520 USA ABBVIE DRUG 2. RECRUITING 1 3018

YEARSN/A

MULTIPLE MYELOMA

NCT01822613 USA NOVARTIS DRUG 2. RECRUITING 1 9918

YEARSN/A

ESOPHAGEAL CARCINOMA

NCT01897038 USAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 1 5418

YEARSN/A LIVER CANCER

NCT01336634 USA GSK DRUG 2. RECRUITING 2 6018

YEARSN/A CANCER

Studies opening Additional Sites in a Country, from Page 36

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 38)(Return to Page 1)

Page 38: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 38

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01436487 USA ATHERSYS BIOLOGICAL 2. RECRUITING 2 14018

YEARS83

YEARSISCHEMIC STROKE

NCT01696045 USA BMS BIOLOGICAL 2. RECRUITING 2 3012

YEARS17

YEARSMELANOMA

NCT01786668 USA PFIZER DRUG 2. RECRUITING 2 20018

YEARSN/A

ANKYLOSING SPONDYLITIS

NCT01830985 USA VERTEX DRUG 2. RECRUITING 2 4018

YEARS65

YEARSRHEUMATOID ARTHRITIS

NCT01854047 USA SANOFI DRUG 2. RECRUITING 2 60018

YEARSN/A ASTHMA

NCT01872689 USAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 2 25040

YEARSN/A

PULMONARY FIBROSIS

NCT01261325 USA UCB DRUG 2. RECRUITING 3 72016

YEARS80

YEARSEPILEPSY

NCT01386528 USANOVO NORDISK

DRUG 2. RECRUITING 3 1213

YEARS70

YEARSHAEMOPHILIA B

NCT01445678 USA CUBIST DRUG 2. RECRUITING 3 50018

YEARSN/A

INTRA- ABDOMINAL INFECTION

NCT01480479 USA CELLDEX DRUG 2. RECRUITING 3 44018

YEARSN/A GLIOBLASTOMA

NCT01544491 USA NOVARTIS DRUG 2. RECRUITING 3 106 N/A18

YEARSRENAL TRANSPLANT

NCT01571284 USA SANOFI DRUG 2. RECRUITING 3 90018

YEARSN/A

COLORECTAL CANCER

NCT01600092 USA MERCK BIOLOGICAL 2. RECRUITING 3 924 6 WEEKS12

WEEKS

ROTAVIRUS GASTROEN-TERITIS

NCT01610414 USA GSK BIOLOGICAL 2. RECRUITING 3 1,47418

YEARSN/A

HERPES ZOSTER

NCT01663402 USA SANOFI DRUG 2. RECRUITING 3 18,00040

YEARSN/A

ACUTE CORONARY SYNDROME

NCT01712516 USA NOVARTIS DRUG 2. RECRUITING 3 1,000 40 YEARS N/A COPD

NCT01727141 USA NOVARTIS DRUG 2. RECRUITING 3 1,000 40 YEARS N/A COPD

NCT01764997 USA SANOFI DRUG 2. RECRUITING 3 70018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01768572 USA SANOFI DRUG 2. RECRUITING 3 20018

YEARSN/A

RHEUMATOID ARTHRITIS

NCT01776424 USA BAYER DRUG 2. RECRUITING 3 19,50018

YEARSN/A

CARDIOVASCU-LAR EVENTS

NCT01798706 USA SANOFI DRUG 2. RECRUITING 3 34070

YEARSN/A

TYPE 2 DIABETES

NCT01868061 USAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 1,05018

YEARS75

YEARSASTHMA

NCT01875003 USAHOFFMANN-LA ROCHE

DRUG 2. RECRUITING 3 37512

YEARS17

YEARSASTHMA

NCT01410890 USA GENZYME BIOLOGICAL 2. RECRUITING 4 20 8 YEARS18

YEARSACID MALTASE DEFICIENCY

Studies opening Additional Sites in a Country, from Page 37

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies opening Additional Sites in a Country, Page 39)(Return to Page 1)

Page 39: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 39

ideNTifier1 CouNTry SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT00685750 USA GSK PROCEDURE 2. RECRUITING NA 160 18 YEARS N/A LUNG CANCER

NCT01492504 USA BMS DRUG 2. RECRUITING NA 990 18 YEARS N/A HEPATITIS C

Studies opening Additional Sites in a Country, from Page 38

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(Return to Page 1)

COUNTRY

STUDIES OPENING A

FIRST SITE IN A NEW COUNTRY

STUDIES OPENING ADDITIONAL SITES

IN A COUNTRYTOTAL

TRIALS

ARGENTINA 5 5 10

AUSTRALIA 5 8 13

AUSTRIA 3 7 10

BELGIUM 6 14 20

BRAZIL 4 4 8

BULGARIA 3 7 10

CANADA 10 14 24

CHILE 0 4 4

CHINA 2 0 2

COLOMBIA 3 4 7

CROATIA 0 4 4

CZECH REPUBLIC

5 9 14

DENMARK 3 6 9

EGYPT 0 2 2

ESTONIA 0 8 8

FINLAND 1 10 11

FRANCE 6 13 19

GERMANY 16 17 33

GREECE 1 3 4

GUATEMALA 0 2 2

HONG KONG 2 5 7

HUNGARY 5 12 17

ICELAND 0 1 1

INDIA 2 5 7

IRELAND 0 3 3

ISRAEL 8 10 18

ITALY 3 14 17

JAPAN 6 8 14

KOREA, SOUTH 6 9 15

LATVIA 1 5 6

LEBANON 1 1 2

STudy SiTeS by CouNTryThis table lists all countries with first-time and additional study sites that launched in the past week.

COUNTRY

STUDIES OPENING A

FIRST SITE IN A NEW COUNTRY

STUDIES OPENING ADDITIONAL SITES

IN A COUNTRYTOTAL

TRIALS

LITHUANIA 3 3 6

MACEDONIA 0 1 1

MALAYSIA 2 2 4

MEXICO 4 9 13

MOLDOVA, REPUBLIC OF

0 1 1

NETHERLANDS 4 9 13

NEW ZEALAND 5 5 10

NORWAY 3 5 8

PANAMA 0 2 2

PERU 1 3 4

PHILIPPINES 2 1 3

POLAND 8 13 21

PORTUGAL 0 2 2

ROMANIA 2 7 9

RUSSIA 9 7 16

SERBIA 1 3 4

SINGAPORE 2 3 5

SLOVAKIA 3 5 8

SLOVENIA 0 2 2

SOUTH AFRICA 5 7 12

SPAIN 5 18 23

SWEDEN 3 10 13

SWITZERLAND 0 2 2

TAIWAN 6 5 11

THAILAND 2 4 6

TURKEY 2 3 5

UKRAINE 2 2 4

UNITED KINGDOM

11 16 27

UNITED STATES

31 33 64

VIETNAM 1 0 1

Page 40: INsIde thIs Issue - FDAnews · For more details, see New Studies on Page 2. New Results: ... NCT01928056 TORRENT DRUG 4. COMPLETED 1 MISS-ING 18 YEARS 45 YEARS HEALTHY NCT01928069

CliniCal Trial Magnifier Weekly Aug. 29, 2013page 40

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N) miN AGe mAX AGe CoNdiTioN

NCT01691261 PFIZER BIOLOGICAL 1. PLANNING 1 10 61 YEARS N/AMACULAR DEGENERATION

NCT01691807 GSK DRUG 1. PLANNING 1 30 18 YEARS N/A CANCER

NCT01705158 ARCAGY DRUG 1. PLANNING 1 88 18 YEARS N/A OVARIAN CANCER

NCT01728207 IMMUNOMEDICS DRUG 1. PLANNING 1 50 18 YEARS N/ALYMPHOCYTIC LYMPHOMA

NCT01744808 NEUROVANCE DRUG 1. PLANNING 1 58 18 YEARS45

YEARSNORMAL, HEALTHY VOLUNTEERS

NCT01745120 BLUEBIRD GENETIC 1. PLANNING 1 15 18 YEARS35

YEARSBETA-THALASSEMIA MAJOR

NCT01748864 ENDOCYTE DRUG 1. PLANNING 1 10 18 YEARS N/A HEALTHY

NCT01636128CANCER PREVENTION

DRUG 1. PLANNING 2 16 40 YEARS65

YEARSBIOMARKERS

NCT01640847 CELSION DRUG 1. PLANNING 2 52 18 YEARS N/A ADENOCARCINOMA

NCT01750931 GSK DRUG 1. PLANNING 2 28 18 YEARS45

YEARSARTHRITIS, RHEUMATOID

NCT01755598 GSK BIOLOGICAL 1. PLANNING 2 4,500 18 YEARS50

YEARSTUBERCULOSIS VACCINES

NCT01769027 CNS ONLUS DRUG 1. PLANNING 2 30 4 YEARS40

YEARSPANDAS

NCT01622569 OPTINOSE DRUG 1. PLANNING 3 320 18 YEARS N/ABILATERAL NASAL POLYPOSIS

NCT01623310 OPTINOSE DRUG 1. PLANNING 3 200 18 YEARS N/A CHRONIC SINUSITIS

NCT01623323 OPTINOSE DRUG 1. PLANNING 3 700 18 YEARS N/A CHRONIC SINUSITIS

NCT01624662 OPTINOSE DRUG 1. PLANNING 3 320 18 YEARS N/ABILATERAL NASAL POLYPOSIS

NCT01626794 MERCK BIOLOGICAL 1. PLANNING 3 52012

MONTHS23

MONTHSVARICELLA

NCT01652209 PHARMICELL BIOLOGICAL 1. PLANNING 3 135 20 YEARS70

YEARSACUTE INFARCTION

NCT01659801 HANITA DEVICE 1. PLANNING 3 35 40 YEARS80

YEARSCATARACT

NCT01667393 IDEV DEVICE 1. PLANNING 3 318 18 YEARS N/APERIPHERAL VASCULAR DISEASE

NCT01670552 EMS DRUG 1. PLANNING 3 206 18 YEARS65

YEARSDYSPEPSIA

NCT01693120 MEDTRONIC DEVICE 1. PLANNING 3 300 18 YEARS70

YEARSPERSISTENT ATRIAL FIBRILLATION

NCT01694966 COSMO DRUG 1. PLANNING 3 1,270 50 YEARS75

YEARSCOLORECTAL CANCER

NCT01701349 OXIGENE DRUG 1. PLANNING 3 300 18 YEARS N/AANAPLASTIC THYROID CANCER

STudieS uNder plANNiNG

This table lists all registered studies that are still under planning, have no site location listed and was first registered during the past year. About 10% of the studies listed as in the planning stage are replaced each week.

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies under planning, Page 41)(Return to Page 1)

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CliniCal Trial Magnifier WeeklyAug. 29, 2013 page 41

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N) miN AGe mAX AGe CoNdiTioN

NCT01709084 JANSSEN DRUG 1. PLANNING 3 426 18 YEARS N/A HIV

NCT01751126 NOVAGALI DRUG 1. PLANNING 3 168 4 YEARS18

YEARSVERNAL KERATO-CONJUNCTIVITIS

NCT01753180 MATRIZYME BIOLOGICAL 1. PLANNING 3MISS-ING

18 YEARS80

YEARSCHRONIC TOTAL OCCLUSIONS

NCT01613677 NOVARTIS DRUG 1. PLANNING 4 27 18 YEARS N/A CERVICAL CANCER

NCT01692470 JANSSEN DRUG 1. PLANNING 4 60 18 YEARS N/A HIV

NCT01727271 MERCK DRUG 1. PLANNING 4 150 18 YEARS N/A HEPATITIS B

NCT01758198 BMS BIOLOGICAL 1. PLANNING 4 300 20 YEARS N/ARHEUMATOID ARTHRITIS

NCT01629719 ALKO 1. PLANNING NA 73 18 YEARS N/A X-RAY GI

NCT01638286 HANMI 1. PLANNING NA 24 20 YEARS45

YEARSACUTE LOW BACK PAIN

NCT01645371 ASTRAZENECA 1. PLANNING NA 70 18 YEARS84

YEARSOPIOID-INDUCED CONSTIPATION

NCT01674764 AOSPINE PROCEDURE 1. PLANNING NA 300 18 YEARS N/AACUTE SPINAL CORD INJURY

NCT01683305 SILBIOTECH 1. PLANNING NA 500 18 YEARS N/A TUMORS

NCT01685047 ST JUDE 1. PLANNING NA 470 18 YEARS N/ACORONARY ARTERY DISEASE

NCT01688011 CELGENE 1. PLANNING NA 1,500 18 YEARS N/AACUTE MYELOID LEUKEMIA

NCT01700543 ZIMMER PROCEDURE 1. PLANNING NA 160 18 YEARS80

YEARSRHEUMATOID ARTHRITIS

NCT01719263 UPTAKE DEVICE 1. PLANNING NA 69 40 YEARS 75 YEARS EMPHYSEMA

NCT01728103 GEN-PROBE DEVICE 1. PLANNING NA 2,100 16 YEARS N/ATRICHOMONAS INFECTIONS

NCT01728714 ASTRAZENECA 1. PLANNING NA 250 18 YEARS N/A DIABETES TYPE 2

NCT01733368 ST JUDE 1. PLANNING NA 200 18 YEARS N/A HEART FAILURE

NCT01735188 ALEXION OTHER 1. PLANNING NA 30 N/A N/ASULFITE OXIDASE DEFICIENCIES

NCT01741025 SI-BONE DEVICE 1. PLANNING NA 100 21 YEARS70

YEARSSACROILIAC JOINT PAIN

NCT01751139 GSK PROCEDURE 1. PLANNING NA 1,500 6 MONTHS N/A DENGUE VACCINES

Studies under planning, from Page 40

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

(See Studies ended or Halted, Page 42)(Return to Page 1)

ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01793649 GILEAD DRUG 5. SUSPENDED 1 12 18 YEARS 45 YEARS COPD

NCT01870297 ELI LILLY DRUG 5. SUSPENDED 1 74 21 YEARS 70 YEARSTYPE 2 DIABETES MELLITUS

NCT01546350REPROGE-NETICS

GENETIC 5. SUSPENDED 2 200 32 YEARS 42 YEARS PREGNANCY LOSS

STudieS eNded or HAlTed

This table lists studies that were terminated, suspended or withdrawn in the past week.

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CliniCal Trial Magnifier Weekly Aug. 29, 2013page 42

1 Identifier: The official study ID given by ClinicalTrials.gov. 2 When the type field is empty, it is commonly a noninterventional study. 3 “NA” in the Phase field indicates that the sponsor has not provided any trial phase information; “NA” commonly represents a noninterventional study, but it can also represent an interventional device trial.

Clinical Trial Magnifier Limited: Managing Director, Johan PE Karlberg fdAnews: president, Cynthia Carter; Content director: Dan Landrigan; executive editor: Meg BryantCopyright © 2013 by Clinical Trial Magnifier. All rights reserved. Clinical Trial Magnifier Weekly is produced jointly by Clinical Trial Magni-fier Limited, which is responsible for the content, and FDAnews, which is responsible for production and distribution. Clinical Trial Magni-fier Weekly (ISSN 2306-8388) monitors all the essential changes made in the U.S. trial registry for industry-sponsored clinical studies. It is published weekly, 52 issues. Price for nonprofit, academic, government, hospital, and study site subscribers, $697. Price for for-profit, in-dustry, and clinical research organizations, $1,297. For site license pricing, contact Nelly Valentin, [email protected]. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permission.

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ideNTifier1 SpoNSor Type2 STATuS pHASe3 SiZe (N)

miN AGe

mAX AGe CoNdiTioN

NCT01694485 AMGEN BIOLOGICAL 5. SUSPENDED 2 360 18 YEARS 65 YEARS ULCERATIVE COLITIS

NCT00014131CALIFORNIA STEM CELL

BIOLOGICAL 7. TERMINATED 1 9 16 YEARS N/A KIDNEY CANCER

NCT01114503 GSK DRUG 7. TERMINATED 1 30 18 YEARS 75 YEARSGRAVES OPHTHALMOPATHY

NCT00413192 EISAI DRUG 7. TERMINATED 2 128 18 YEARS N/ASOFT TISSUE SARCOMA

NCT00505570 AGA DEVICE 7. TERMINATED 2 10718

YEARS65

YEARSPFO

NCT00814593CALIFORNIA STEM CELL

BIOLOGICAL 7. TERMINATED 2 80 18 YEARS N/A BRAIN TUMORS

NCT01602367 BMS DRUG 7. TERMINATED 2 718

YEARS80

YEARSHYPERTENSION

NCT01705496 BIOMED RADIATION 7. TERMINATED 2 24 18 YEARS N/APROSTHETIC INFECTIONS

NCT01764919 BIOMED RADIATION 7. TERMINATED 2 4 18 YEARS N/ADIABETIC FOOT INFECTION

NCT01308437WOCK-HARDT

BIOLOGICAL 7. TERMINATED 3 134 18 YEARS 55 YEARS TYPE I DIABETES

NCT00292500 CARDICA DEVICE 7. TERMINATED NA 170 50 YEARS 85 YEARSCORONARY ARTERY DISEASE

NCT01197209MOMOTARO-GENE

BIOLOGICAL 8. WITHDRAWN 1 0 20 YEARS 75 YEARS PROSTATE CANCER

NCT01697514 ELI LILLY DRUG 8. WITHDRAWN 1 012

MONTHS21 YEARS

RHABDOMYOSAR-COMA

NCT01721135 GSK DRUG 8. WITHDRAWN 1 0 18 YEARS 65 YEARS ASTHMA

NCT01404117 TEVA DRUG 8. WITHDRAWN 2 0 18 YEARS 55 YEARSMULTIPLE SCLEROSIS

NCT01723579 MERCK DRUG 8. WITHDRAWN 3 0 18 YEARS 45 YEARS CONTRACEPTION

NCT01757015 NOVARTIS DRUG 8. WITHDRAWN 3 0 40 YEARS N/A COPD

NCT01380665 KCI DEVICE 8. WITHDRAWN 4 0 18 YEARS N/AKNEE ARTHROPLASTY

NCT00234559 KCI DEVICE 8. WITHDRAWN NA 0 18 YEARS N/A WOUNDS

NCT01701947 FRANCAIS BIOLOGICAL 8. WITHDRAWN NA MISS-ING

6 MONTHS N/A SURGERY

Studies ended or Halted, from Page 41