Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Sponsored by Merck Sharp & Dohme LLC
About this study
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.
As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.
Where this study is enrolling (20)
- Call 909-558-5830
Loma Linda University Health System ( Site 0008)
San Bernardino, California
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- Call 310-825-9111
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California
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- Call 650-721-2121
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California
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- Call 720-777-1234
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado
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- Call 888-884-2327
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia
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Show all 20 locations
- Call 727-898-7451
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida
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- Call 404-785-7174
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia
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- Call 617-355-4213
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts
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- Call 734-615-0590
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan
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- Call 800-678-4357
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri
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- Call 212-305-5437
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York
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- Call 718-741-2426
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York
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- Call 216-444-2200
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio
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- Call 513-636-3016
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio
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- Call 412-692-5325
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania
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- Call 215-590-7000
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania
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- Call 901-287-5760
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee
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- I'm interested
Texas Children's Hospital ( Site 0039)
Houston, Texas
- Call 214-456-7000
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas
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- Call 206-987-2015
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington
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Who can participate
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.
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.