drugset / Trial / NCT01140581
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dronedarone | Small molecule | 400 mg | Oral |