ESSENTIAL Protocol No. My-021 and Protocol No. My-026, Each Titled: A Phase III, Randomized, Double-Blind, Multicenter, Parallel Group, Placebo-Controlled Study of Oral Enoximone vs. Placebo in Advanced Chronic Heart Failure Subjects
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,800
- 主要终点
- Time from randomization to all-cause mortality or cardiovascular hospitalization
研究概览
简要总结
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
详细描述
The study is a randomized, double-blind, multicenter, parallel group, placebo-controlled trial of oral enoximone in approximately 700 subjects with advanced chronic heart failure of either ischemic or nonischemic etiology receiving optimal conventional heart failure therapy.
Eligible subjects will be randomized in a 1:1 ratio to receive either enoximone or placebo at the Randomization Visit. The initial dose of study drug will be 25 mg t.i.d.(3xday) and will be administered immediately after randomization. Subjects who tolerate this initial dose will be continued on 25 mg t.i.d. for at least two weeks. After two weeks, eligible subjects will be titrated to 50 mg t.i.d. for the duration of the study.
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
- 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
Enoximone
干预措施: Enoximone (Drug)
Placebo
干预措施: Enoximone placebo (Drug)
结局指标
主要结局
Time from randomization to all-cause mortality or cardiovascular hospitalization
时间窗: Baseline to Month 6
次要结局
- Change in Patient Global Assessment score(Baseline to Month 6)
- Change in Six-Minute Walk Test(Baseline to Month 6)