NCT00697086已完成3 期
Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change from baseline in mean ventricular rate at rest and during exercise
研究概览
简要总结
The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.
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
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic permanent AF (>6 months) for which cardioversion is not considered and resting ventricular rate > or equal 80 bpm at screening measured on a 6-seconds rhythm strip,
排除标准
- •Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes
- •Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted
- •Clinically overt congestive heart failure at randomization
- •Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug
- •Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease
- •Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Dronedarone (SR33589) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in mean ventricular rate at rest and during exercise
时间窗: Day 14
次要结局
未报告次要终点
研究者
研究点 (1)
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