Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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.
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)
Key Details
Gender
All
Age Range
29 Days - 17 Years
Study Type
INTERVENTIONAL
Enrollment
342
Start Date
2023-05-31
Completion Date
2032-04-15
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
Locations (103)
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, United States
Loma Linda University Health System ( Site 0008)
San Bernardino, California, United States
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado, United States
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, United States
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts, United States
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, United States
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, United States
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, United States
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio, United States
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee, United States
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas, United States
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, United States
Centre Hospitalier Régional de la Citadelle ( Site 0302)
Liège, Liege, Belgium
UZ Gent ( Site 0301)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0300)
Leuven, Vlaams-Brabant, Belgium
Instituto Dante Pazzanese de Cardiology ( Site 0402)
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao ( Site 0400)
São Paulo, Brazil
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta, Canada
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec, Canada
Clinica Somer ( Site 0607)
Rionegro, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0608)
Barranquilla, Atlántico, Colombia
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
Bogotá, Bogota D.C., Colombia
Fundación Valle del Lili ( Site 0604)
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department, Colombia
Klinički bolnički centar Zagreb ( Site 3700)
Zagreb, City of Zagreb, Croatia
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen, Capital Region, Denmark
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere, Pirkanmaa, Finland
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac, Aquitaine, France
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille, Nord, France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
Nantes, Pays de la Loire Region, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
Paris, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
Paris, France
Universitaetsklinikum Freiburg ( Site 1102)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg ( Site 1100)
Heidelberg, Baden-Wurttemberg, Germany
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
Erlangen, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 1108)
Hanover, Lower Saxony, Germany
Deutsches Herzzentrum Berlin ( Site 1101)
Berlin, Germany
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, Hungary
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, Ireland
IRCCS Istituto Giannina Gaslini ( Site 1603)
Genoa, Liguria, Italy
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
Milan, Lombardy, Italy
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
Rome, Roma, Italy
A.O.Universitaria Meyer ( Site 1600)
Florence, Tuscany, Italy
Azienda Ospedale - Università Padova ( Site 1601)
Padova, Veneto, Italy
Hospital Universiti Sains Malaysia ( Site 1703)
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre ( Site 1701)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Queen Elizabeth II ( Site 1706)
Kota Kinabalu, Sabah, Malaysia
Hospital Tunku Azizah-Paediatric ( Site 1700)
Kuala Lumpur, Malaysia
Institut Jantung Negara ( Site 1705)
Kuala Lumpur, Malaysia
Morales Vargas Centro de Investigacion ( Site 1810)
León, Guanajuato, Mexico
CINVEC Medica ( Site 1814)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria ( Site 1803)
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
Monterrey, Nuevo León, Mexico
INVECORDIS S.C. ( Site 1808)
Hacienda de Las Palmas, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
Ciudad Madero, Tamaulipas, Mexico
Centro de Atención e Investigación Clínica ( Site 1813)
Aguascalientes, Mexico
UROLAP ( Site 1812)
Colima, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
México, Mexico
Erasmus Medisch Centrum ( Site 1900)
Rotterdam, South Holland, Netherlands
University Medical Center Groningen ( Site 1901)
Groningen, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1902)
Utrecht, Netherlands
Auckland City Hospital ( Site 2000)
Auckland, New Zealand
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
Jesús María, Lima, Peru
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
Gdansk, Pomeranian Voivodeship, Poland
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
Lisbon, Portugal
Unidade Local de Saúde de São João ( Site 2403)
Porto, Portugal
Childrens University Hospital ( Site 4200)
Belgrade, Beograd, Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
Belgrade, Beograd, Serbia
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
Novi Sad, Vojvodina, Serbia
National University Hospital-Paediatrics ( Site 2600)
Singapore, South West, Singapore
KK Women's and Children's Hospital ( Site 2601)
Singapore, South West, Singapore
TREAD Research ( Site 2700)
Cape Town, Western Cape, South Africa
Children's Heart Disease Research Unit ( Site 2704)
Cape Town, Western Cape, South Africa
Pusan National University Yangsan Hospital ( Site 2802)
Pusan, Kyongsangnam-do, South Korea
Seoul National University Hospital ( Site 2803)
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 2800)
Seoul, South Korea
Samsung Medical Center ( Site 2801)
Seoul, South Korea
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 2903)
Barcelona, Catalonia, Spain
Hospital Materno-Infantil Teresa Herrera ( Site 2905)
A Coruña, La Coruna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Paz ( Site 2912)
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
Seville, Spain
Skånes Universitetssjukhus Lund ( Site 3000)
Lund, Skåne County, Sweden
Astrid Lindgrens Barnsjukhus ( Site 3001)
Solna, Stockholm County, Sweden
Faculty of Medicine Siriraj Hospital ( Site 3200)
Bangkoknoi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3202)
Muang, Changwat Khon Kaen, Thailand
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, Thailand
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara, Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi ( Site 3301)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
Ankara, Turkey (Türkiye)
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
Istanbul, Turkey (Türkiye)
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir, Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom
Freeman Hospital ( Site 3400)
Newcastle upon Tyne, United Kingdom