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 |
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.
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
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