NCT01067859终止2 期
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 5
- 主要终点
- Pulmonary Capillary Wedge Pressure
研究概览
简要总结
A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of 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
- •Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
- •Subjects must have the clinical diagnosis of Congestive Heart Failure (CHF) made at least three months prior to enrollment
- •Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
- •dyspnea and
- •clinical evidence of volume overload
排除标准
- •Acute de-novo heart failure
- •Acute myocardial infarction and/or myocardial infarction within 30 days
- •Valvular heart disease requiring surgical intervention during the course of the study
- •Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
- •Primary hypertrophic cardiomyopathy
- •Acute inflammatory heart disease, eg, acute myocarditis
- •Unstable angina requiring angiography
研究组 & 干预措施
Arm 1
Experimental
干预措施: Cinaciguat (BAY58-2667) (Drug)
Arm 2
Experimental
干预措施: Cinaciguat (BAY58-2667) (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary Capillary Wedge Pressure
时间窗: 8 hours
次要结局
- Cardiac index (CI)(8 hours and 48 hours)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Follow up (after 30+5 days))
- Right atrial pressure (RAP)(8 hours and 48 hours)
研究者
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