NCT00212680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
- 100
- 主要终点
- Percentage of patients achieving 20% reduction in heart rate at each dose
研究概览
简要总结
The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.
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
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 years old
- •Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher)
- •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 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 achieving 20% reduction in heart rate at each dose
次要结局
- Heart Rate, Blood pressure and 12-lead ECG
研究者
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