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RECRUITING
NCT05714085
PHASE2/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

View on ClinicalTrials.gov

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

DRUG

Vericiguat tablet

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

DRUG

Vericiguat suspension

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

DRUG

Placebo tablet

Placebo for vericiguat administered orally once daily in tablet form

DRUG

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