Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation Factor Xa inhibition
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 536
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Detailed description:

Arms:
arm 1: DU-176b low dose arm 2: DU-176b intermediate dose arm 3: DU-176b high dose arm 4: Warfarin

Interventions: intervention 1: DU-176b tablets intervention 2: Warfarin potassium tablets
Intervention descriptions: intervention 1: DU-176b tablets taken once daily for up to 12 weeks intervention 2: Warfarin potassium tablets taken once daily for up to 12 weeks

Protocol document: