Overview

Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation

Status:
Completed

Trial end date:
2011-04-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Sanofi

Treatments:

Amiodarone
Dronedarone