TrialPath
← Back to searchRecruiting

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

NCT05714085 · Merck Sharp & Dohme LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)
About this study
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.
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.
Study design
Enrollment target: 342 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2023-05-31
Estimated completion: 2032-04-15
Last updated: 2026-04-13
Interventions
Drug: Vericiguat tabletDrug: Vericiguat suspensionDrug: Placebo tabletDrug: Placebo suspension
Primary outcomes
  • Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) (Baseline and Week 16 of Base Period)
  • Extension Period: Percentage of participants with one or more adverse events (AEs) (Includes data collected up to a maximum of approximately 8 years)
  • Extension Period: Percentage of participants who discontinued study drug due to an AE (Includes data collected up to a maximum of approximately 8 years)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (104)
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)Recruiting
Los Angeles, California, United States
Lucile Packard Children's Hospital ( Site 0040)Recruiting
Palo Alto, California, United States
Loma Linda University Health System ( Site 0008)Recruiting
San Bernardino, California, United States
Children's Hospital Colorado ( Site 0012)Recruiting
Aurora, Colorado, United States
Children's National Medical Center ( Site 0020)Recruiting
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital ( Site 0029)Recruiting
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)Recruiting
Atlanta, Georgia, United States
Boston Children's Hospital ( Site 0035)Recruiting
Boston, Massachusetts, United States
C.S. Mott Children's Hospital ( Site 0033)Recruiting
Ann Arbor, Michigan, United States
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)Recruiting
St Louis, Missouri, United States
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)Recruiting
New York, New York, United States
The Children's Hospital at Montefiore ( Site 0030)Recruiting
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center ( Site 0034)Recruiting
Cincinnati, Ohio, United States
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)Recruiting
Cleveland, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 0004)Recruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh ( Site 0010)Recruiting
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital ( Site 0007)Recruiting
Memphis, Tennessee, United States
Children's Health-The Heart Center ( Site 0015)Recruiting
Dallas, Texas, United States
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)Recruiting
Seattle, Washington, United States
Centre Hospitalier Régional de la Citadelle ( Site 0302)Recruiting
Liège, Liege, Belgium
UZ Gent ( Site 0301)Recruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0300)Recruiting
Leuven, Vlaams-Brabant, Belgium
Instituto Dante Pazzanese de Cardiology ( Site 0402)Recruiting
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao ( Site 0400)Recruiting
São Paulo, Brazil
Stollery Children's Hospital ( Site 0501)Recruiting
Edmonton, Alberta, Canada
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)Recruiting
Sherbrooke, Quebec, Canada
Clinica Somer ( Site 0607)Recruiting
Rionegro, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0608)Recruiting
Barranquilla, Atlántico, Colombia
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)Recruiting
Bogotá, Bogota D.C., Colombia
Fundación Valle del Lili ( Site 0604)Recruiting
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0602)Recruiting
Cali, Valle del Cauca Department, Colombia
Klinički bolnički centar Zagreb ( Site 3700)Recruiting
Zagreb, City of Zagreb, Croatia
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)Recruiting
Copenhagen, Capital Region, Denmark
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)Recruiting
Tampere, Pirkanmaa, Finland
CHU Bordeaux Haut-Leveque ( Site 1000)Completed
Pessac, Aquitaine, France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)Completed
Nantes, Loire-Atlantique, France
CHU Lille - Institut Coeur Poumon ( Site 1005)Completed
Lille, Nord, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)Completed
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Universitaire Necker Enfants Malades ( Site 1001)Completed
Paris, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)Completed
Paris, France
Universitaetsklinikum Freiburg ( Site 1102)Recruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg ( Site 1100)Completed
Heidelberg, Baden-Wurttemberg, Germany
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)Recruiting
Erlangen, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 1108)Recruiting
Hanover, Lower Saxony, Germany
Deutsches Herzzentrum Berlin ( Site 1101)Recruiting
Berlin, Germany
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)Recruiting
Budapest, Hungary
Children's Health Ireland (CHI) at Crumlin ( Site 1400)Recruiting
Dublin, Ireland
IRCCS Istituto Giannina Gaslini ( Site 1603)Recruiting
Genoa, Liguria, Italy
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)Recruiting
Milan, Lombardy, Italy
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)Recruiting
Rome, Roma, Italy
A.O.Universitaria Meyer ( Site 1600)Completed
Florence, Tuscany, Italy
Azienda Ospedale - Università Padova ( Site 1601)Recruiting
Padova, Veneto, Italy
Hospital Universiti Sains Malaysia ( Site 1703)Recruiting
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre ( Site 1701)Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Queen Elizabeth II ( Site 1706)Recruiting
Kota Kinabalu, Sabah, Malaysia
Hospital Tunku Azizah-Paediatric ( Site 1700)Recruiting
Kuala Lumpur, Malaysia
Institut Jantung Negara ( Site 1705)Recruiting
Kuala Lumpur, Malaysia
Morales Vargas Centro de Investigacion ( Site 1810)Recruiting
León, Guanajuato, Mexico
CINVEC Medica ( Site 1814)Recruiting
Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria ( Site 1803)Recruiting
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)Recruiting
Monterrey, Nuevo León, Mexico
INVECORDIS S.C. ( Site 1808)Recruiting
Hacienda de Las Palmas, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)Recruiting
Ciudad Madero, Tamaulipas, Mexico
Centro de Atención e Investigación Clínica ( Site 1813)Recruiting
Aguascalientes, Mexico
UROLAP ( Site 1812)Recruiting
Colima, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)Recruiting
México, Mexico
Erasmus Medisch Centrum ( Site 1900)Recruiting
Rotterdam, South Holland, Netherlands
University Medical Center Groningen ( Site 1901)Recruiting
Groningen, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1902)Recruiting
Utrecht, Netherlands
Auckland City Hospital ( Site 2000)Recruiting
Auckland, New Zealand
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)Recruiting
Jesús María, Lima, Peru
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)Completed
Gdansk, Pomeranian Voivodeship, Poland
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)Recruiting
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)Recruiting
Lisbon, Portugal
Unidade Local de Saúde de São João ( Site 2403)Recruiting
Porto, Portugal
Childrens University Hospital ( Site 4200)Recruiting
Belgrade, Beograd, Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)Recruiting
Belgrade, Beograd, Serbia
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)Recruiting
Novi Sad, Vojvodina, Serbia
National University Hospital-Paediatrics ( Site 2600)Recruiting
Singapore, South West, Singapore
KK Women's and Children's Hospital ( Site 2601)Recruiting
Singapore, South West, Singapore
TREAD Research ( Site 2700)Recruiting
Cape Town, Western Cape, South Africa
Children's Heart Disease Research Unit ( Site 2704)Recruiting
Cape Town, Western Cape, South Africa
Pusan National University Yangsan Hospital ( Site 2802)Recruiting
Pusan, Kyongsangnam-do, South Korea
Seoul National University Hospital ( Site 2803)Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 2800)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 2801)Recruiting
Seoul, South Korea
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)Recruiting
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 2903)Recruiting
Barcelona, Catalonia, Spain
Hospital Materno-Infantil Teresa Herrera ( Site 2905)Recruiting
A Coruña, La Coruna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Paz ( Site 2912)Recruiting
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)Recruiting
Seville, Spain
Skånes Universitetssjukhus Lund ( Site 3000)Recruiting
Lund, Skåne County, Sweden
Astrid Lindgrens Barnsjukhus ( Site 3001)Recruiting
Solna, Stockholm County, Sweden
Faculty of Medicine Siriraj Hospital ( Site 3200)Recruiting
Bangkoknoi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3202)Completed
Muang, Changwat Khon Kaen, Thailand
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)Recruiting
Chiang Mai, Thailand
Hacettepe Universite Hastaneleri ( Site 3304)Recruiting
Ankara, Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi ( Site 3301)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 3300)Recruiting
Ankara, Turkey (Türkiye)
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)Recruiting
Istanbul, Turkey (Türkiye)
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)Recruiting
Izmir, Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)Recruiting
London, London, City of, United Kingdom
Freeman Hospital ( Site 3400)Recruiting
Newcastle upon Tyne, United Kingdom
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) · TrialPath