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Clinical Trials in Ireland / NCT05714085
Recruiting Phase 2/3

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

NCT05714085 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2/3
Started
2023-05-31
Last updated
2026-08-28

Condition(s) studied

Heart FailureLeft Ventricular Systolic Dysfunction

Investigational drug(s) / intervention(s)

Vericiguat tabletVericiguat suspensionPlacebo tabletPlacebo suspension

Vericiguat tablet: 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form

Vericiguat suspension: 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form

Placebo tablet: Placebo for vericiguat administered orally once daily in tablet form

Placebo suspension: Placebo for vericiguat administered orally once daily in suspension form

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.

Eligibility

Sex
ALL
Min age
29 Days
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction. * Has biventricular physiology with a morphologic systemic left ventricle. * Is currently receiving stable medical therapy for HF. * Has left ventricular ejection fraction (LVEF) \<45% assessed within 3 months before randomization. * Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate. * Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; 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 their medical history; their menstrual history, and recent sexual activity has been reviewed. * Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period Exclusion Criteria: * Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic. * Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator. * Has a history of single ventricle heart disease or has a morphologic systemic right ventricle. * Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device. * Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy. * Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations. * Has unoperated or residual hemodynamically significant congenital cardiac malformations. * Has hypertrophic or restrictive cardiomyopathy. * Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis. * Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization. * Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease * Has severe pulmonary hypertension. * Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease. * Has severe chronic kidney disease. * Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C. * Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications. * Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation * Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator. * Has received a COVID-19 vaccination within 1 week before randomization.

Primary outcome measure(s)

Trial sites (109)

FacilityCityRegionStatus
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) Los Angeles California Recruiting
Lucile Packard Children's Hospital ( Site 0040) Palo Alto California Recruiting
Loma Linda University Health System ( Site 0008) San Bernardino California Recruiting
Children's Hospital Colorado ( Site 0012) Aurora Colorado Recruiting
Children's National Medical Center ( Site 0020) Washington D.C. District of Columbia Recruiting
Johns Hopkins All Children's Hospital ( Site 0029) St. Petersburg Florida Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001) Atlanta Georgia Recruiting
Boston Children's Hospital ( Site 0035) Boston Massachusetts Recruiting
C.S. Mott Children's Hospital ( Site 0033) Ann Arbor Michigan Recruiting
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006) St Louis Missouri Recruiting
Columbia University Medical Center-Pediatric Cardiology ( Site 0016) New York New York Recruiting
The Children's Hospital at Montefiore ( Site 0030) The Bronx New York Recruiting
Cincinnati Children's Hospital Medical Center ( Site 0034) Cincinnati Ohio Recruiting
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022) Cleveland Ohio Recruiting
Children's Hospital of Philadelphia (CHOP) ( Site 0004) Philadelphia Pennsylvania Recruiting
Children's Hospital of Pittsburgh ( Site 0010) Pittsburgh Pennsylvania Recruiting
Le Bonheur Children's Hospital ( Site 0007) Memphis Tennessee Recruiting
Children's Health-The Heart Center ( Site 0015) Dallas Texas Recruiting
Texas Children's Hospital ( Site 0039) Houston Texas Recruiting
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019) Seattle Washington Recruiting
Centre Hospitalier Régional de la Citadelle ( Site 0302) Liège Liege Recruiting
UZ Gent ( Site 0301) Ghent Oost-Vlaanderen Recruiting
UZ Leuven ( Site 0300) Leuven Vlaams-Brabant Recruiting
Instituto Dante Pazzanese de Cardiology ( Site 0402) São Paulo São Paulo Recruiting
Incor - Instituto do Coracao ( Site 0400) São Paulo Brazil Recruiting
Stollery Children's Hospital ( Site 0501) Edmonton Alberta Recruiting
The Hospital for Sick Children ( Site 0500) Toronto Ontario Recruiting
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502) Sherbrooke Quebec Recruiting
Clinica Somer ( Site 0607) Rionegro Antioquia Recruiting
Ciensalud Ips S A S ( Site 0608) Barranquilla Atlántico Recruiting
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603) Bogotá Bogota D.C. Recruiting
Fundación Valle del Lili ( Site 0604) Cali Valle del Cauca Department Recruiting
Clínica Imbanaco S.A.S ( Site 0602) Cali Valle del Cauca Department Recruiting
Klinički bolnički centar Zagreb ( Site 3700) Zagreb City of Zagreb Recruiting
Rigshospitalet-BørneUngeAfdelingen ( Site 0800) Copenhagen Capital Region Recruiting
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900) Tampere Pirkanmaa Recruiting
CHU Bordeaux Haut-Leveque ( Site 1000) Pessac Aquitaine Completed
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002) Nantes Loire-Atlantique Completed
CHU Lille - Institut Coeur Poumon ( Site 1005) Lille Nord Completed
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003) Marseille Provence-Alpes-Côte d'Azur Region Completed

+ 69 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in Ireland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05714085 on ClinicalTrials.gov ↗ ← All trials in Ireland