NCT00126074已完成3 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation or Flutter
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 30
研究概览
简要总结
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to sign informed consent before screening examinations are performed and before the study drug is administered
- •Females > 18 years of age
- •Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
- •Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg)
排除标准
- •Pregnancy and lactation
- •Acute myocardial infarction and cerebrovascular accidents
- •Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
- •Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- •Concurrent antiarrhythmic treatments
研究者
研究点 (30)
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