DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with
non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient
basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind
DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses.
Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the
Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary
endpoints are incidence of major, clinically relevant non-major and minor bleeding events
(all bleeding).