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

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: Systolic Dysfunction
• Intervention / Treatment: Drug: Vericiguat tablet; Drug: Vericiguat suspension

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	Percentage of participants with AEs	Up to approximately 8 years
Participants who discontinued study drug due to an AE	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)	Change in NT-proBNP from baseline at Week 16.	Baseline and Week 16

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

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: Cardiovascular Diseases; Heart Diseases; Heart Murmurs; Ventricular Dysfunction; Heart Failure; Ventricular Dysfunction, Left; Systolic Murmurs; vericiguat
• 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