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NCT05714085
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Conditions: Heart Failure, Left Ventricular Systolic Dysfunction
Sex: All
Ages: 29 Days – 17 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 342
Sponsor: Merck Sharp & Dohme LLC
Location: The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) Los Angeles California
Summary
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.
Eligibility Criteria
Inclusion Criteria:
* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.
* Has biventricular physiology with a morphologic systemic left ventricle.
* Is currently receiving stable medical therapy for HF.
* Has left ventricular ejection fraction (LVEF) \28 days to \
Source: ClinicalTrials.gov (NCT05714085). StuddyBuddy aggregates publicly available trial information.