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Looking for participantsPhase2/Phase3

Efficacy, 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

NCT ID: NCT05714085

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Vericiguat tablet (drug), Vericiguat suspension (drug), Placebo tablet (drug), Placebo suspension (drug)
How long the study runs
Study runs about 107 months (dates as stated)
About the drug or intervention
Vericiguat tablet — drug: 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form · Vericiguat suspension — drug: 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form · Placebo tablet — drug: Placebo for vericiguat administered orally once daily in tablet form · Placebo suspension — drug: Placebo for vericiguat administered orally once daily in suspension form
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called vericiguat in children and young people, from just after birth up to under 18 years old, who have heart failure caused by a weakened main pumping chamber (the left ventricle). The researchers want to find out how well the medicine works, how safe it is, and how the body handles it. The study is run by Merck Sharp & Dohme LLC.

Who can take part

  • Has symptomatic long-term heart failure caused by the heart's main pumping chamber (the left ventricle) not squeezing well
  • Has the usual two-ventricle heart structure, with a normal-shaped left ventricle
  • Is already on steady heart failure treatment that is not changing
  • Has a pumping strength (ejection fraction) of the left ventricle below 45%, measured within 3 months before joining
  • Is over 28 days old and under 18 years old, of any sex or gender, and weighs at least 3 kg
  • If female, must not be pregnant or breastfeeding, and must either be unable to have children or use a highly effective contraceptive method; a negative pregnancy test is needed, and breastfeeding must be avoided during the study and for at least 30 days after
  • For the extension part: must have been randomly assigned to a group, taken at least one dose of the study medicine (vericiguat or placebo), not stopped it permanently, and finished the Week 52 visit and safety follow-up of the main study period

Who may not be able to

  • Is clinically unstable, for example has low blood pressure with symptoms, recently had heart-strengthening or blood-vessel-widening medicine by drip, or recently had water-tablet medicine by drip
  • Is allergic or sensitive to vericiguat, its ingredients, or similar medicines (soluble guanylate cyclase stimulators)
  • Has single-ventricle heart disease or a right ventricle doing the main pumping job
  • Has had a heart transplant, is waiting for an urgent (Class 1A) heart transplant, is on continuous drip heart-strengthening medicine, or has an implanted heart pump device
  • Has a lasting or symptomatic abnormal heart rhythm that is not controlled by medicine or a device
  • Has had recent heart surgery or a key-hole procedure to fix or ease a heart problem present from birth
  • Has uncorrected or remaining significant heart problems present from birth that affect blood flow
  • Has thickened or stiff heart muscle disease (hypertrophic or restrictive cardiomyopathy)
  • Has active inflammation of the heart (myocarditis) or was recently diagnosed with it
  • Has a sudden heart artery problem (acute coronary syndrome), had a recent heart artery procedure, or needs one planned
  • Has symptomatic narrowing of the neck arteries or other symptomatic blood vessel disease in the brain
  • Has severe high blood pressure in the lungs
  • Needs continuous oxygen at home for serious lung disease or has known scarring of the lungs (interstitial lung disease)
  • Has severe long-term kidney disease
  • Has serious liver problems, such as confusion from liver disease, abnormal liver blood tests, or the most severe Child-Pugh class (Class C)
  • Has a gut or bile problem that could affect how medicines are absorbed or removed from the body
  • Has significant bone disease (other than mild thinning) that could affect bone formation
  • Is taking or expected to take certain medicines (phosphodiesterase type 5 inhibitors or soluble guanylate cyclase stimulators) alongside the study medicine
  • Has had a COVID-19 vaccination within 1 week before joining

What taking part involves

  • • Taking the study medicine vericiguat or a placebo (a dummy medicine with no active ingredient) — which one is decided by chance
  • • Attending study visits, including a Week 52 visit and a safety follow-up period
  • • There may be an option to continue into an extension period after the main study period

Time commitment: The main study period lasts at least 52 weeks, with a safety follow-up afterwards, and involves regular study visits and taking study medicine — full details of visit frequency and total length: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
29 Days to 17 Years
Who
All
Number of participants
342
Started
2023-05-31
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase2/Phase3 - 342 participants
  • • 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

Who can take part?

  • • Ages 29 Days to 17 Years
  • • Diagnosed with heart failure

Where?

  • • London - Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
  • • Newcastle upon Tyne - Freeman Hospital ( Site 3400)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Heart FailureLeft Ventricular Systolic Dysfunction

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 29 Days - 17 Years
  • Who can join: All genders

Biomarkers mentioned

has a negative

What the study is looking for

  • ✓Has causing symptoms 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.

Who cannot take part

  • ✗Is clinically unstable-with at least one of the following: has causing symptoms hypotension or is hypotensive for age,...
  • ✗Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase...
  • ✗Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.
  • ✗Has sustained or causing symptoms dysrhythmia uncontrolled with drug or device therapy.
  • ✗Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital...
See the full 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.

Where Is This Study? (2 UK sites)

Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)

London WC1N 3JH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 7405 9200

Freeman Hospital ( Site 3400)

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator07899895040

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08