Skip to content

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
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501238-52-00
Acronym
MK-1242-036
Enrollment
111
Registered
2023-02-24
Start date
2023-03-23
Completion date
Unknown
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure due to systemic left ventricular systolic dysfunction

Brief summary

Base Period: Change from baseline to Week 16 in log-transformed n-terminal pro-brain natriuretic peptide (NT-proBNP), Extension Period: Percentage of participants with one or more adverse events (AE), Extension Period: Percentage of participants who discontinued study drug due to an AE

Detailed description

Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP, Base Period: Time from randomization to the first event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization, Base Period: Percentage of participants with one or more adverse events (AE), Base Period: Percentage of participants who discontinued study drug due to an AE, Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat, Base Period: Half-life (t1/2) of vericiguat in plasma, Base Period: Oral clearance (CL/F) of plasma vericiguat, Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP

Interventions

DRUGVericiguat
DRUGPlacebo to MK-1242 tablet 2.5 ; 5 and 10 mg; and oral suspension

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Base Period: Change from baseline to Week 16 in log-transformed n-terminal pro-brain natriuretic peptide (NT-proBNP), Extension Period: Percentage of participants with one or more adverse events (AE), Extension Period: Percentage of participants who discontinued study drug due to an AE

Secondary

MeasureTime frame
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP, Base Period: Time from randomization to the first event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization, Base Period: Percentage of participants with one or more adverse events (AE), Base Period: Percentage of participants who discontinued study drug due to an AE, Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat, Base Period: Half-life (t1/2) of vericiguat in plasma, Base Period: Oral clearance (CL/F) of plasma vericiguat, Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP

Countries

Belgium, Croatia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026