NCT00212654已完成2 期
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Percentage of patients who met the heart rate reduction criteria (20% reduction from the baseline heart rate and a heart rate of <100 beats/min)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.
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
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years or older
- •Postoperative supraventricular tachyarrhythmias
- •Within 7 days postoperatively
- •Other inclusion criteria as specified in the protocol
排除标准
- •Acute myocardial infarction (within 1 month after onset)
- •Severe heart failure [New York Heart Association (NYHA) functional class III or higher]
- •Atrioventricular block (grade II or higher), or sick sinus syndrome
- •Other exclusion criteria as specified in the protocol
结局指标
主要结局
Percentage of patients who met the heart rate reduction criteria (20% reduction from the baseline heart rate and a heart rate of <100 beats/min)
次要结局
- Heart rate, blood pressure, rate-pressure-product and ECG
研究者
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