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)
Merck Sharp & Dohme LLC
342 participants
May 31, 2023
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo for vericiguat administered orally once daily in tablet form
Placebo for vericiguat administered orally once daily in suspension form
Locations(105)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05714085