Conditions: Atrial Fibrillation Thromboembolism
Keywords: Anti-coagulant Non-valvular Venous Thromboembolism Prevention of Blood Clots Atrial Fibrillation Non-valvular atrial fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1146
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: DU-176b 30mg tablet once daily arm 2: DU-176b 60mg once daily arm 3: DU-176b 30mg b.i.d. arm 4: DU-176b 60mg tablets two times a day arm 5: warfarin tablets

Interventions: intervention 1: Edoxaban (DU-176b) intervention 2: Edoxaban (DU-176b) intervention 3: Edoxaban (DU-176b) intervention 4: Edoxaban (DU-176b) intervention 5: warfarin
Intervention descriptions: intervention 1: 30mg tablet once daily intervention 2: 60mg tablet once daily intervention 3: 30mg tablet two times a day intervention 4: 60mg tablet two times a day intervention 5: warfarin tablets

Protocol document: