Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation sinus rhythm amiodarone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 504
Healthy volunteers: no

Brief summary:
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Detailed description:

Arms:
arm 1: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg arm 2: over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets

Interventions: intervention 1: dronedarone (SR33589) intervention 2: amiodarone
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration

Protocol document: