Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) — Baseline and Week 16 of Base Period
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported. - Extension Period: Percentage of participants with one or more adverse events (AEs) — Includes data collected up to a maximum of approximately 8 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported. - Extension Period: Percentage of participants who discontinued study drug due to an AE — Includes data collected up to a maximum of approximately 8 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Trial sites (109)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
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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 Spain