Atrial Fibrillation
Conditions
Brief 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.
Detailed description
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.
Interventions
Pharmaceutical form: tablets Route of administration: oral
DRUGplacebo
Pharmaceutical form: tablets Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of aged 20 years or more. * Permanent Atrial Fibrillation \[AF\] (defined as duration of AF \> 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.
Exclusion criteria
* Unstable angina pectoris. * History of torsades de pointes. * Prolonged QT corrected interval (≥ 500 ms). * Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval \> 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted. * Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III. * Treatment with other class I or III anti-arrhythmic drugs. * Patients treated with amiodarone during the 4 weeks preceding randomization. * Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease. * Hypokalemia and hypomagnesemia must be corrected before randomization. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG) | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | up to 10 days after last drug intake |
| Plasma trough concentrations for SR33589 | Day 14 |
| Plasma trough concentrations for SR35021 | Day 14 |
Countries
Japan
Outcome results
None listed