Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

• Status: Completed
• Trial end date: 2012-04-01

Summary

Primary Objective:

• Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

• Explore potential PK interaction between Dronedarone and Amiodarone

• Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)

• To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Amiodarone; Dronedarone