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

Last updated: July 3, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Heart Failure

Congestive Heart Failure

Hyponatremia

Treatment

Vericiguat suspension

Vericiguat tablet

Clinical Study ID

NCT06428383
1242-043
2023-506210-40-00
MK-1242-043
U1111-1293-4744
  • Ages > 1
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Was randomized, received at least 1 dose of study intervention (vericiguat orplacebo), and completed the Week 52 visit and safety follow-up period for the VALORbase study.

  • A participant assigned female sex at birth is not pregnant or breastfeeding, and isnot a participant/participants of childbearing potential (POCBP) or is a POCBP whoUses a contraceptive method that is highly effective, has a negative highlysensitive pregnancy test, abstains from breastfeeding during the study interventionperiod and for at least 30 days after study intervention., and whose medicalhistory, menstrual history, and recent sexual activity has been reviewed by theinvestigator to decrease the risk for inclusion of a POCBP with an early undetectedpregnancy.

  • Is able to receive medication via the oral or gastric route .

Exclusion

Exclusion Criteria:

  • Is hypotensive for age at Visit 1

  • Has a known allergy or sensitivity to vericiguat, any of its constituents, or anyother 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 inhibitorsduring 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 Design

Total Participants: 342
Treatment Group(s): 2
Primary Treatment: Vericiguat suspension
Phase: 3
Study Start date:
July 03, 2024
Estimated Completion Date:
September 15, 2025

Connect with a study center

  • Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)

    Rionegro, Antioquia 054040
    Colombia

    Site Not Available

  • Fundacion Valle del Lili- CIC ( Site 0604)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)

    Budapest, 1096
    Hungary

    Site Not Available

  • Children's Health Ireland (CHI) at Crumlin ( Site 1400)

    Dublin, D12 N512
    Ireland

    Site Not Available

  • Faculty of Medicine Siriraj Hospital ( Site 3200)

    Thailand, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Le Bonheur Children's Hospital ( Site 0007)

    Memphis, Tennessee 38103
    United States

    Site Not Available

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