NCT00281554已完成3 期
A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
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
- 254
- 主要终点
- Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
研究概览
简要总结
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject must have symptomatic AF
- •Subject must have adequate anticoagulant therapy
排除标准
- •Subject may not have Class IV congestive heart failure.
- •Subject may not have uncorrected electrolyte imbalance.
研究组 & 干预措施
1
Experimental
干预措施: RSD1235 (Drug)
结局指标
主要结局
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
时间窗: Infusion plus 1.5 hours
次要结局
- Evaluate safety(End of study)
研究者
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