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Dronedarone Dose-Ranging Study for Ventricular Rate Control in Japanese Patients with Permanent Atrial Fibrillation
NCT01213368Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Apr 2011
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- dronedarone
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 2, randomised, double-blind trial of dronedarone in Atrial fibrillation (AFib) (4 arms), sponsored by Sanofi. Primary endpoint: Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG). Started Sep 2010; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Dronedarone 300 mg
Dronedarone 300 mg BID
Dronedarone 400 mg
Dronedarone 400 mg BID
Dronedarone 600 mg
Dronedarone 600 mg BID
Placebo
Matching placebo BID
03
Who it enrols
Japanese patients aged 20+ with permanent AF (>6 months) and resting ventricular rate >= 80 bpm. Excludes unstable angina, history of Torsades de Pointes, QTc >= 500 ms, AV block without pacemaker, NYHA IV or unstable III HF, and recent amiodarone use.
04
Endpoints
Primary
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
Secondary
Number of patients with adverse events
Plasma trough concentrations for SR33589
Plasma trough concentrations for SR35021
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