Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 633
- 试验地点
- 142
- 主要终点
- Reducing the recurrence of all-cause shocks plus symptomatic ATP
研究概览
简要总结
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.
The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 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 (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Placebo tablets
干预措施: placebo (Drug)
2
75 mg azimilide
干预措施: Azimilide Dihydrochloride (Drug)
3
125 mg azimilide
干预措施: Azimilide Dihydrochloride (Drug)
结局指标
主要结局
Reducing the recurrence of all-cause shocks plus symptomatic ATP
时间窗: one year
次要结局
未报告次要终点