drugset / Trial / NCT01199081
Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dronedarone | Small molecule | 400 mg | Oral |