NCT00041496已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of SB 207266 in Patients With Symptomatic Persistent Atrial Fibrillation (AF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 520
- 主要终点
- Time-to-first symptomatic AF (atrial fibrillation)
研究概览
简要总结
The purpose of this study is to determine whether the study drug is effective in preventing the recurrence of atrial fibrillation (an abnormal heart rhythm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Symptomatic persistent atrial fibrillation requiring DC cardioversion.
- •Duration of AF >48 hrs. <6 months
排除标准
- •Concomitant Class I and/or III anti-arrhythmic drugs.
- •Amiodarone treatment within 3 months of the study.
- •Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
研究组 & 干预措施
Arm 1
Experimental
Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo
干预措施: SB-207266 (Drug)
Arm 2
Placebo Comparator
Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Time-to-first symptomatic AF (atrial fibrillation)
时间窗: Up to 26 Weeks
次要结局
- Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion(Up to 26 Weeks)
研究者
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