NCT04318093已完成2 期
A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure
Bristol-Myers Squibb14 个研究点 分布在 6 个国家目标入组 25 人开始时间: 2020年11月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 14
- 主要终点
- Percentage of Participants Experiencing Clinically Relevant Hypotension
研究概览
简要总结
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for 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
- •Participants currently hospitalized for acute decompensated heart failure (ADHF)
- •Participants must be hemodynamically stable, as assessed by the investigator
- •Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
- •Women participants must have documented proof that they are not of childbearing potential
排除标准
- •Acute cardiovascular condition other than heart failure (HF) decompensation
- •Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
- •Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
- •Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986259
Experimental
干预措施: BMS-986259 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Experiencing Clinically Relevant Hypotension
时间窗: From first dose to 30 days following first dose
Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) \<85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP \<90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
次要结局
- Maximum Observed Serum Concentration (Cmax)(Day 1 and Day 5 of study treatment)
- Time of Maximum Observed Serum Concentration (Tmax)(Day 1 and Day 5 of study treatment)
- Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))(Day 1 and Day 5 of study treatment)
- Trough Concentration (Ctrough)(Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available))
研究者
研究点 (14)
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