NCT00115791已完成3 期
A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
研究概览
简要总结
The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days
排除标准
- •Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
研究组 & 干预措施
1
Experimental
干预措施: RSD1235 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
时间窗: Infusion plus 1.5 hours
次要结局
- To assess the time taken from exposure to first treatment to first conversion to sinus rhythm(End of study)
研究者
研究点 (1)
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