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
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