NCT00520806已完成2 期
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies3 个研究点 分布在 2 个国家目标入组 1,161 人开始时间: 2007年10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
- 1,161
- 试验地点
- 3
- 主要终点
- Relief of dyspnea in acute heart failure
研究概览
简要总结
Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure
详细描述
This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.
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
- •Hospitalized for acute heart failure
- •Dyspnea at rest or with minimal exertion
- •Pulmonary congestion
- •Able to provide informed consent
- •Systolic blood pressure > 125 mmHg
- •Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2
排除标准
- •Use of other IV therapies for acute heart failure
- •Fever or sepsis
- •Recent major neurologic event
- •Recent major surgery
- •Recent acute coronary syndrome
- •Other recent investigational drug use
研究组 & 干预措施
Placebo
Placebo Comparator
48 hour iv infusion of placebo
干预措施: Placebo (Drug)
Relaxin
Experimental
48 hour iv infusion of relaxin at 30 ug/kg/day
干预措施: Relaxin (Drug)
结局指标
主要结局
Relief of dyspnea in acute heart failure
时间窗: Up to day 5
次要结局
- Days alive and out of hospital(Up to day 60)
- CV death or rehospitalization due to heart failure or renal failure(Up to day 60)
研究者
研究点 (3)
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