Recruiting

Phase 2

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT05714085

Conditions

Heart Failure

Left Ventricular Systolic Dysfunction

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Vericiguat tablet

Vericiguat suspension

Placebo tablet

Placebo suspension

Study Details

Brief 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.

Conditions

Heart Failure

Left Ventricular Systolic Dysfunction

Study ID

NCT05714085

Start date

May 31, 2023

Status verified date

Aug, 2026

Completion date

Apr 15, 2032

Anticipated

Primary completion date

Apr 15, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

342 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Base Period: Vericiguat

Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks.

placebo comparator: Base Period: Placebo

Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.

experimental: Extension Period: Vericiguat

Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.

Interventions

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

Primary outcome measure

Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline and Week 16 of Base Period ]
Extension Period: Percentage of participants with one or more adverse events (AEs) [ Time Frame: Includes data collected up to a maximum of approximately 8 years ]
Extension Period: Percentage of participants who discontinued study drug due to an AE [ Time Frame: Includes data collected up to a maximum of approximately 8 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-825-9111

Lucile Packard Children's Hospital ( Site 0040)

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Coordinator

650-721-2121

Loma Linda University Health System ( Site 0008)

Recruiting

San Bernardino, California, United States, 92408

Contacts

Study Coordinator

909-558-5830

Children's Hospital Colorado ( Site 0012)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-777-1234

Children's National Medical Center ( Site 0020)

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Study Coordinator

888-884-2327

Johns Hopkins All Children's Hospital ( Site 0029)

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Study Coordinator

727-898-7451

Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Study Coordinator

404-785-0381

Boston Children's Hospital ( Site 0035)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Study Coordinator

617-355-4213

C.S. Mott Children's Hospital ( Site 0033)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-615-0590

Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

800-678-4357

Columbia University Medical Center-Pediatric Cardiology ( Site 0016)

Recruiting

New York, New York, United States, 10032

Contacts

Study Coordinator

212-305-5437

The Children's Hospital at Montefiore ( Site 0030)

Recruiting

The Bronx, New York, United States, 10467

Contacts

Study Coordinator

718-741-2426

Cincinnati Children's Hospital Medical Center ( Site 0034)

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Study Coordinator

513-636-3016

Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Study Coordinator

216-444-2200

Children's Hospital of Philadelphia (CHOP) ( Site 0004)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-590-1000

Children's Hospital of Pittsburgh ( Site 0010)

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Study Coordinator

412-692-5325

Le Bonheur Children's Hospital ( Site 0007)

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Study Coordinator

901-287-5760

Children's Health-The Heart Center ( Site 0015)

Recruiting

Dallas, Texas, United States, 75235

Contacts

Study Coordinator

214-456-7000

Texas Children's Hospital ( Site 0039)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

832-826-2806

Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)

Recruiting

Seattle, Washington, United States, 98105

Contacts

Study Coordinator

206-987-2015

Stollery Children's Hospital ( Site 0501)

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Study Coordinator

780-407-1586

The Hospital for Sick Children ( Site 0500)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Study Coordinator

416-813-1500

Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H4

Contacts

Study Coordinator

819-346-1110, 12889

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.