Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

Recruiting Phase 2 Phase 3 Interventional Study
Heart Failure Left Ventricular Systolic Dysfunction
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
29 Days – 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
342 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
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About This Trial

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.

Trial Locations
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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 fra…
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