NCT01064037终止2 期
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)
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
- 62
- 主要终点
- Dyspnea VAS (using a visual analogue scale)
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 ovarectomy, 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 4
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Cinaciguat (BAY58-2667) (Drug)
Arm 2
Experimental
干预措施: Cinaciguat (BAY58-2667) (Drug)
Arm 3
Experimental
干预措施: Cinaciguat (BAY58-2667) (Drug)
结局指标
主要结局
Dyspnea VAS (using a visual analogue scale)
时间窗: 8 hours
次要结局
- Dyspnea assessment (Likert Scale)(up to follow-up (30 - 35 days))
- Dyspnea assessment through Likert scale(Up to follow up visit)
- Overall health status assessment (EQ-5D)(up to follow-up (30 - 35 days))
- Global clinical assessment by the physician(At 8, 24, and 48 hours)
- Changes in the dyspnea VAS at other time points(Up to follow up visit)
- Change in concomitant medications(During the treatment)
- Overall health status assessment through EQ-5D Health Questionnaire(Up to the follow-up visit)
- Safety variables(Up to end of study)
研究者
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