drugset / Trial / NCT00742859

Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin

NCT00742859

Phase 2 Completed 508 enrolled Portola Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
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

Indications