A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation



Status:Completed
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:2/28/2019
Start Date:June 2007
End Date:June 2008

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A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation

This study is to assess the safety of a potential new drug DU-176b for the prevention of
stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation
(AF). The duration is 3 months of treatment and a 30 day follow-up visit.


Inclusion Criteria:

1. Male or female, 18 to 80 years old.

2. Able to provide written informed consent.

3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)

4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke
(CHADS2) index score of at least 2

Exclusion Criteria:

1. Subjects with mitral valve disease or previous valvular heart surgery

2. Known contraindication to any anticoagulant including vitamin K antagonists such as
warfarin

3. Known or suspected hereditary or acquired bleeding or coagulation disorder
We found this trial at
23
sites
1402
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Bellevue, WA
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Albany, NY
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Allentown, PA
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Anaheim, CA
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801
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Atlanta, GA
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Beverly Hills, California 90211
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Beverly Hills, CA
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786
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Cadillac, MI
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783
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Canton, GA
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349
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Dallas, TX
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715
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Fort Wayne, IN
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264
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Fremont, NE
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660
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Huntsville, AL
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429
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Iowa City, IA
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1098
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Kalispell, MT
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1118
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Minsk,
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158
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Oklahoma City, OK
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1139
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Orlando, FL
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1199
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Pottstown, PA
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779
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Salt Lake City, UT
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475
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Santa Fe, NM
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1143
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Sarasota, FL
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Sellersville, Pennsylvania 18960
1217
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Sellersville, PA
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1278
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Stockton, CA
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