Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form