drugset / Trial / NCT01199081

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

NCT01199081

Phase 4 Completed 154 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2010-10
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral

Indications