NCT06122779进行中（未招募）2 期
A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 227
- 试验地点
- 282
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.
排除标准
- •Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
BMS-986435
Experimental
干预措施: BMS-986435 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)
时间窗: Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation
时间窗: Up to approximately 20 weeks
次要结局
- Summary of plasma concentrations of MYK-224(Up to approximately 20 weeks)
研究者
研究点 (282)
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