Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 174
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.

Detailed description:

Arms:
arm 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration arm 3: Dose-adjusted warfarin based on target INR values

Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Warfarin
Intervention descriptions: intervention 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration intervention 3: Dose-adjusted warfarin based on target INR values

Protocol document: