NCT00057356已完成2 期
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure
Cumberland Pharmaceuticals26 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2002年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 26
- 主要终点
- Change from baseline in respiratory Visual analog Scale (VAS)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients may be male or female age 18 years or older.
- •Women must be post-menopausal or surgically sterile.
- •Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.
排除标准
- 未提供
研究组 & 干预措施
2
Experimental
Low dose
干预措施: conivaptan (Drug)
1
Placebo Comparator
干预措施: placebo (Drug)
3
Experimental
Middle dose
干预措施: conivaptan (Drug)
4
Experimental
High dose
干预措施: conivaptan (Drug)
结局指标
主要结局
Change from baseline in respiratory Visual analog Scale (VAS)
时间窗: 48 hours
次要结局
- Change from baseline in global VAS(48 hours)
- Total urine output vs. baseline(72 hours)
研究者
研究点 (26)
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