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

NCT ID: NCT05714085

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2032-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Left Ventricular Systolic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Vericiguat tablet

Intervention Type DRUG

2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form

Vericiguat suspension

Intervention Type DRUG

0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form

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.

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

Placebo for vericiguat administered orally once daily in tablet form

Placebo suspension

Intervention Type DRUG

Placebo for vericiguat administered orally once daily in suspension form

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.

Group Type EXPERIMENTAL

Vericiguat tablet

Intervention Type DRUG

2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form

Vericiguat suspension

Intervention Type DRUG

0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form

Interventions

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Vericiguat tablet

2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form

Intervention Type DRUG

Vericiguat suspension

0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form

Intervention Type DRUG

Placebo tablet

Placebo for vericiguat administered orally once daily in tablet form

Intervention Type DRUG

Placebo suspension

Placebo for vericiguat administered orally once daily in suspension form

Intervention Type DRUG

Other Intervention Names

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MK-1242 MK-1242 Placebo for MK-1242 Placebo for MK-1242

Eligibility Criteria

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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.
Minimum Eligible Age

29 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Loma Linda University Health System ( Site 0008)

Loma Linda, California, United States

Site Status RECRUITING

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

Los Angeles, California, United States

Site Status RECRUITING

Children's Hospital Colorado ( Site 0012)

Aurora, Colorado, United States

Site Status RECRUITING

Children's National Medical Center ( Site 0020)

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

Site Status RECRUITING

Johns Hopkins All Children's Hospital ( Site 0029)

St. Petersburg, Florida, United States

Site Status RECRUITING

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

Atlanta, Georgia, United States

Site Status RECRUITING

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

Ann Arbor, Michigan, United States

Site Status RECRUITING

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

St Louis, Missouri, United States

Site Status RECRUITING

Columbia University Medical Center-Pediatric Cardiology ( Site 0016)

New York, New York, United States

Site Status RECRUITING

The Children's Hospital at Montefiore ( Site 0030)

The Bronx, New York, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center ( Site 0034)

Cincinnati, Ohio, United States

Site Status RECRUITING

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

Cleveland, Ohio, United States

Site Status RECRUITING

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

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh ( Site 0010)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Le Bonheur Children's Hospital ( Site 0007)

Memphis, Tennessee, United States

Site Status RECRUITING

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

Dallas, Texas, United States

Site Status RECRUITING

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

Seattle, Washington, United States

Site Status RECRUITING

Centre Hospitalier Régional de la Citadelle ( Site 0302)

Liège, Liege, Belgium

Site Status RECRUITING

UZ Gent ( Site 0301)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

UZ Leuven ( Site 0300)

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Instituto Dante Pazzanese de Cardiology ( Site 0402)

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Incor - Instituto do Coracao ( Site 0400)

São Paulo, , Brazil

Site Status RECRUITING

Stollery Children's Hospital ( Site 0501)

Edmonton, Alberta, Canada

Site Status RECRUITING

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

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Clinica Somer ( Site 0607)

Rionegro, Antioquia, Colombia

Site Status RECRUITING

Ciensalud Ips S A S ( Site 0608)

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

Fundación Valle del Lili ( Site 0604)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Clínica Imbanaco S.A.S ( Site 0602)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Rigshospitalet-BørneUngeAfdelingen ( Site 0800)

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)

Tampere, Pirkanmaa, Finland

Site Status RECRUITING

CHU Bordeaux Haut-Leveque ( Site 1000)

Pessac, Aquitaine, France

Site Status COMPLETED

CHU Lille - Institut Coeur Poumon ( Site 1005)

Lille, Nord, France

Site Status COMPLETED

Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)

Nantes, Pays de la Loire Region, France

Site Status RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)

Marseille, Provence-Alpes-Côte d'Azur Region, France

Site Status RECRUITING

Hôpital Universitaire Necker Enfants Malades ( Site 1001)

Paris, , France

Site Status RECRUITING

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)

Paris, , France

Site Status COMPLETED

Universitaetsklinikum Freiburg ( Site 1102)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universitaetsklinikum Heidelberg ( Site 1100)

Heidelberg, Baden-Wurttemberg, Germany

Site Status COMPLETED

Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)

Erlangen, Bavaria, Germany

Site Status RECRUITING

Medizinische Hochschule Hannover ( Site 1108)

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Deutsches Herzzentrum Berlin ( Site 1101)

Berlin, , Germany

Site Status RECRUITING

Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)

Budapest, , Hungary

Site Status RECRUITING

Children's Health Ireland (CHI) at Crumlin ( Site 1400)

Dublin, , Ireland

Site Status RECRUITING

IRCCS Istituto Giannina Gaslini ( Site 1603)

Genoa, Liguria, Italy

Site Status RECRUITING

A.O.Universitaria Meyer ( Site 1600)

Florence, Tuscany, Italy

Site Status RECRUITING

Azienda Ospedale - Università Padova ( Site 1601)

Padua, Veneto, Italy

Site Status RECRUITING

Hospital Universiti Sains Malaysia ( Site 1703)

Kota Bharu, Kelantan, Malaysia

Site Status RECRUITING

University Malaya Medical Centre ( Site 1701)

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status RECRUITING

Hospital Queen Elizabeth II ( Site 1706)

Kota Kinabalu, Sabah, Malaysia

Site Status RECRUITING

Hospital Tunku Azizah-Paediatric ( Site 1700)

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Institut Jantung Negara ( Site 1705)

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Morales Vargas Centro de Investigacion ( Site 1810)

León, Guanajuato, Mexico

Site Status RECRUITING

CINVEC Medica ( Site 1814)

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Instituto Nacional de Pediatria ( Site 1803)

Mexico City, Mexico City, Mexico

Site Status RECRUITING

INVECORDIS S.C. ( Site 1808)

Hacienda de Las Palmas, State of Mexico, Mexico

Site Status RECRUITING

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)

Ciudad Madero, Tamaulipas, Mexico

Site Status RECRUITING

Centro de Atención e Investigación Clínica ( Site 1813)

Aguascalientes, , Mexico

Site Status RECRUITING

Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)

México, , Mexico

Site Status RECRUITING

Erasmus Medisch Centrum ( Site 1900)

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

University Medical Center Groningen ( Site 1901)

Groningen, , Netherlands

Site Status RECRUITING

Universitair Medisch Centrum Utrecht ( Site 1902)

Utrecht, , Netherlands

Site Status RECRUITING

Auckland City Hospital ( Site 2000)

Auckland, , New Zealand

Site Status RECRUITING

Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)

Jesús María, Lima, Peru

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)

Gdansk, Pomeranian Voivodeship, Poland

Site Status COMPLETED

Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)

Lisbon, , Portugal

Site Status RECRUITING

Unidade Local de Saúde de São João ( Site 2403)

Porto, , Portugal

Site Status RECRUITING

National University Hospital-Paediatrics ( Site 2600)

Singapore, South West, Singapore

Site Status RECRUITING

KK Women's and Children's Hospital ( Site 2601)

Singapore, South West, Singapore

Site Status RECRUITING

TREAD Research ( Site 2700)

Cape Town, Western Cape, South Africa

Site Status RECRUITING

Children's Heart Disease Research Unit ( Site 2704)

Cape Town, Western Cape, South Africa

Site Status RECRUITING

Pusan National University Yangsan Hospital ( Site 2802)

Pusan, Kyongsangnam-do, South Korea

Site Status RECRUITING

Seoul National University Hospital ( Site 2803)

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System ( Site 2800)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 2801)

Seoul, , South Korea

Site Status RECRUITING

Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)

Esplugues de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron ( Site 2903)

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Materno-Infantil Teresa Herrera ( Site 2905)

A Coruña, La Coruna, Spain

Site Status RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitario La Paz ( Site 2912)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)

Seville, , Spain

Site Status RECRUITING

Skånes Universitetssjukhus Lund ( Site 3000)

Lund, Skåne County, Sweden

Site Status RECRUITING

Astrid Lindgrens Barnsjukhus ( Site 3001)

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 3200)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 3202)

Muang, Changwat Khon Kaen, Thailand

Site Status COMPLETED

Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)

Chiang Mai, , Thailand

Site Status RECRUITING

Hacettepe Universite Hastaneleri ( Site 3304)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Baskent Universitesi Ankara Hastanesi ( Site 3301)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent Şehir Hastanesi. ( Site 3300)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

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

London, London, City of, United Kingdom

Site Status RECRUITING

Freeman Hospital ( Site 3400)

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Brazil Canada Colombia Denmark Finland France Germany Hungary Ireland Italy Malaysia Mexico Netherlands New Zealand Peru Poland Portugal Singapore South Africa South Korea Spain Sweden Thailand Turkey (Türkiye) United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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References

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Fritsch A, Meyer M, Blaustein RO, Trujillo ME, Kauh E, Roessig L, Boettcher M, Becker C. Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat. Clin Pharmacokinet. 2024 Jun;63(6):751-771. doi: 10.1007/s40262-024-01384-1. Epub 2024 Jun 25.

Reference Type DERIVED
PMID: 38916717 (View on PubMed)

Related Links

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https://msd.trialsummaries.com/Study/StudyDetails?id=26221&tenant=MT_MSD_9011

Plain Language Summary

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-1242-036

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501238-52-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1275-1768

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-004399-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1242-036

Identifier Type: -

Identifier Source: org_study_id

NCT06428383

Identifier Type: -

Identifier Source: nct_alias