NCT05714085

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)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 29 Days – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.

Conditions

• Heart Failure
• Left Ventricular Systolic Dysfunction

Interventions

Type	Name	Description
DRUG	Vericiguat tablet	2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
DRUG	Vericiguat suspension	0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
DRUG	Placebo tablet	Placebo for vericiguat administered orally once daily in tablet form
DRUG	Placebo suspension	Placebo for vericiguat administered orally once daily in suspension form

Timeline

• Start date: 2023-05-31
• Primary completion: 2032-04-15
• Completion: 2032-04-15
• First posted: 2023-02-06
• Last updated: 2026-04-13

Locations

104 sites across 29 countries: United States, Belgium, Brazil, Canada, Colombia, Croatia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study