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.
The study period per patient is approximatively 1 month broken down as follows: * Screening period up to 7 days, * Treatment period of 14 days, * Follow-up period of 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
181
Pharmaceutical form: tablets Route of administration: oral
Pharmaceutical form: tablets Route of administration: oral
Investigational Site Number 392022
Hiroshima, Japan
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
Time frame: Day 14
Number of patients with adverse events
Time frame: up to 10 days after last drug intake
Plasma trough concentrations for SR33589
Time frame: Day 14
Plasma trough concentrations for SR35021
Time frame: Day 14
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