NCT05714085 Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
| NCT ID | NCT05714085 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2032-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 342 participants in total. It began in 2023-05-31 with a primary completion date of 2032-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT05714085 clinical trial?
This trial is open to participants of all sexes, aged 29 Days or older, up to 17 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05714085 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05714085 currently recruiting?
Yes, NCT05714085 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT05714085 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, San Bernardino, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT05714085 clinical trial?
NCT05714085 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 342 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.