drugset / Trial / NCT00742859
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-08
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betrixaban | Small molecule | 40 mg | Oral |
| Subject | Betrixaban | Small molecule | 60 mg | Oral |
| Subject | Betrixaban | Small molecule | 80 mg | Oral |
| Comparator | Warfarin | Small molecule | — | — |