drugset / Trial / NCT01140581

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

NCT01140581

Phase 4 Completed 402 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: \- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: * Evaluate the rate of AF recurrences two months after randomization. * Assess the safety of the change from amiodarone to dronedarone * Assess dronedarone safety * Explore dronedarone and its active metabolite plasma level (in a subset of countries) * Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

Timeline

Start
2010-09
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral

Indications