NCT00232297已完成2 期
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 100 OR 300 mg for the Prevention of Ventricular Arrhythmia-Triggered ICD Interventions
适应症
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
- 153
- 试验地点
- 8
- 主要终点
- Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock).
研究概览
简要总结
Primary objective:
- to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions.
Secondary objectives:
- to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population.
- to document SSR149744C plasma level during the study.
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 (Participant, Investigator)
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
- •Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year.
- •Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months.
排除标准
- •MAIN CRITERIA (non-exhaustive list):
- •Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.
结局指标
主要结局
Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock).
次要结局
- Time to all arrhythmia episodes leading to at least one documented ICD shock.
研究者
研究点 (8)
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