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

NCT05714085 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2032-04-15
Completion
2032-04-15
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714085 on ClinicalTrials.gov