2023-506210-40-00已完成3 期
A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 29
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
To monitor safety and tolerability of vericiguat (MK-1242).
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Has received at least 1 dose of study intervention (vericiguat or placebo) and completed the Week 52 visit and safety follow-up period for the VALOR base study. This includes participants who prematurely discontinued study intervention unless premature discontinuation of study intervention was due to a drug related adverse event (AE) or to noncompliance with study intervention
- •Is able to receive medication via the oral or gastric route
排除标准
- •Is hypotensive for age at Visit 1
- •Has undergone heart transplantation or has an implanted ventricular assist device
- •Has severe chronic kidney disease or requires chronic dialysis
- •Has hepatic disorder or Child Pugh Class C
- •Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study
- •Has concurrent or anticipated use of an soluble guanylate cyclase (sGC) stimulator
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Discontinue Study Treatment Due to an AE
次要结局
- Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
研究者
Mackenzie Ford
Scientific
Merck Sharp & Dohme LLC
研究点 (29)
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