Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)

September 19, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)

The primary objective of this study is to monitor the safety and tolerability of vericiguat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)
    • Valle del Cauca Department
      • Santiago de Cali, Valle del Cauca Department, Colombia, 760032
        • Fundacion Valle del Lili- CIC ( Site 0604)
  • Hungary
      • Budapest, Hungary, 1096
        • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
  • Ireland
      • Dublin, Ireland, D12 N512
        • Children's Health Ireland (CHI) at Crumlin ( Site 1400)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
    • Bangkok
      • Thailand, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 3200)
  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital ( Site 0007)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study.
  • A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
  • Is able to receive medication via the oral or gastric route .

Exclusion Criteria:

  • Is hypotensive for age at Visit 1
  • Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
  • Has undergone heart transplantation or has an implanted ventricular assist device.
  • Has severe chronic kidney disease
  • Has hepatic disorder
  • Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
  • Has concurrent or anticipated use of an sGC stimulator.
  • Is both ≥18 years of age and vericiguat is commercially available to the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vericiguat
Vericiguat administered orally in either tablet or suspension once daily until end of treatment
Drug: Vericiguat tablet
Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily
Other Names:
  • MK-1242
Drug: Vericiguat suspension

Vericiguat suspension at doses 0.2 mg/mL,

1 mg/mL taken orally once daily

Other Names:
  • MK-1242

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with adverse events (AEs)
Time Frame: Up to approximately 8 years
Percentage of participants with AEs
Up to approximately 8 years
Participants who discontinued study drug due to an AE
Time Frame: Up to approximately 8 years
Percentage of participants who discontinued study drug due to an AE
Up to approximately 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline and Week 16
Change in NT-proBNP from baseline at Week 16.
Baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Clinical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1242-043
  • MK-1242-043 (Other Identifier: MSD)
  • 2023-506210-40-00 (Registry Identifier: EU CT)
  • U1111-1293-4744 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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