Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
- Registration Number
- NCT01213368
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dronedarone 300 mg DRONEDARONE (SR33589) Dronedarone, 100mg + 200mg tablets twice daily, administered with food. dronedarone 400 mg DRONEDARONE (SR33589) Dronedarone, 400mg tablets twice daily, administered with food. dronedarone 600 mg DRONEDARONE (SR33589) Dronedarone, 400mg + 200mg tablets twice daily, administered with food. placebo placebo Matching placebo tablets twice daily, administered with food.
- Primary Outcome Measures
Name Time Method Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG) Day 14
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events up to 10 days after last drug intake Plasma trough concentrations for SR35021 Day 14 Plasma trough concentrations for SR33589 Day 14
Trial Locations
- Locations (25)
Investigational Site Number 392008
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392019
🇯🇵Nagasaki-Shi, Japan
Investigational Site Number 392010
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392020
🇯🇵Suwa-Shi, Japan
Investigational Site Number 392023
🇯🇵Miyazaki-Shi, Japan
Investigational Site Number 392012
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392013
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392022
🇯🇵Hiroshima-Shi, Japan
Investigational Site Number 392005
🇯🇵Kasama-Shi, Japan
Investigational Site Number 392007
🇯🇵Kisarazu-Shi, Japan
Investigational Site Number 392018
🇯🇵Kagoshima-Shi, Japan
Investigational Site Number 392014
🇯🇵Kawanishi-Shi, Japan
Investigational Site Number 392024
🇯🇵Toshima-Ku, Japan
Investigational Site Number 392003
🇯🇵Koriyama-Shi, Japan
Investigational Site Number 392017
🇯🇵Kurume-Shi, Japan
Investigational Site Number 392009
🇯🇵Nagano-Shi, Japan
Investigational Site Number 392011
🇯🇵Yao-Shi, Japan
Investigational Site Number 392025
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392004
🇯🇵Shirakawa-Shi, Japan
Investigational Site Number 392015
🇯🇵Ube-Shi, Japan
Investigational Site Number 392021
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392016
🇯🇵Shunan-Shi, Japan
Investigational Site Number 392006
🇯🇵Takasaki-Shi, Japan
Investigational Site Number 392002
🇯🇵Sendai-Shi, Japan
Investigational Site Number 392001
🇯🇵Tomakomai-Shi, Japan