NCT06428383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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 7
- 主要终点
- Participants who discontinued study drug due to an AE
研究概览
简要总结
The primary objective of this study is to monitor the safety and tolerability of vericiguat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was randomized, 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.
- •A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
- •Is able to receive medication via the oral or gastric route .
排除标准
- •Is hypotensive for age at Visit 1
- •Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
- •Has undergone heart transplantation or has an implanted ventricular assist device.
- •Has severe chronic kidney disease
- •Has hepatic disorder
- •Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
- •Has concurrent or anticipated use of an sGC stimulator.
- •Is both ≥18 years of age and vericiguat is commercially available to the participant
研究组 & 干预措施
Vericiguat
Experimental
Vericiguat administered orally in either tablet or suspension once daily until end of treatment
干预措施: Vericiguat tablet (Drug)
Vericiguat
Experimental
Vericiguat administered orally in either tablet or suspension once daily until end of treatment
干预措施: Vericiguat suspension (Drug)
结局指标
主要结局
Participants who discontinued study drug due to an AE
时间窗: Up to approximately 8 years
Percentage of participants who discontinued study drug due to an AE
Participants with adverse events (AEs)
时间窗: Up to approximately 8 years
Percentage of participants with AEs
次要结局
- Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)(Baseline and Week 16)
研究者
研究点 (7)
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