NCT01213368已完成2 期
Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 181
- 试验地点
- 25
- 主要终点
- Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dronedarone 300 mg
Experimental
Dronedarone, 100mg + 200mg tablets twice daily, administered with food.
干预措施: DRONEDARONE (SR33589) (Drug)
dronedarone 400 mg
Experimental
Dronedarone, 400mg tablets twice daily, administered with food.
干预措施: DRONEDARONE (SR33589) (Drug)
dronedarone 600 mg
Experimental
Dronedarone, 400mg + 200mg tablets twice daily, administered with food.
干预措施: DRONEDARONE (SR33589) (Drug)
placebo
Placebo Comparator
Matching placebo tablets twice daily, administered with food.
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
时间窗: Day 14
次要结局
- 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)
研究者
研究点 (25)
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