drugset / Trial / NCT01213368
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary Objective: \- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF). Secondary Objective: * To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population. * To document SR33589 and SR35021 trough plasma levels at steady state.
Timeline
- Start
- 2010-09
- Primary completion
- 2011-04
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dronedarone | Small molecule | 300 mg | Oral |
| Subject | Dronedarone | Small molecule | 400 mg | Oral |
| Subject | Dronedarone | Small molecule | 600 mg | Oral |