Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Start Date
5/31/2023
Completion Date
4/15/2032
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.
Detailed Description
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
Age Range: No minimum to 17 years
Interventions
Vericiguat tablet
Vericiguat suspension
Placebo tablet
Placebo suspension
Conditions
Locations
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California 90095
United States
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California 94304
United States
Loma Linda University Health System ( Site 0008)
San Bernardino, California 92408
United States
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado 80045
United States
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia 20010
United States
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida 33701
United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia 30329
United States
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts 02115
United States
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan 48109
United States
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri 63110
United States
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York 10032
United States
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York 10467
United States
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio 45229
United States
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio 44195
United States
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania 19104
United States
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania 15224
United States
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee 38103
United States
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas 75235
United States
Texas Children's Hospital ( Site 0039)
Houston, Texas 77030
United States
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington 98105
United States
Centre Hospitalier Régional de la Citadelle ( Site 0302)
Liège, Liege 4000
Belgium
UZ Gent ( Site 0301)
Ghent, Oost-Vlaanderen 9000
Belgium
UZ Leuven ( Site 0300)
Leuven, Vlaams-Brabant 3000
Belgium
Instituto Dante Pazzanese de Cardiology ( Site 0402)
São Paulo, São Paulo 04012-909
Brazil
Incor - Instituto do Coracao ( Site 0400)
São Paulo, 05403-900
Brazil
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta T6G 2B7
Canada
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec J1H 5H4
Canada
Clinica Somer ( Site 0607)
Rionegro, Antioquia 054040
Colombia
Ciensalud Ips S A S ( Site 0608)
Barranquilla, Atlántico 08001
Colombia
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
Bogotá, Bogota D.C. 110131
Colombia
Fundación Valle del Lili ( Site 0604)
Cali, Valle del Cauca Department 760032
Colombia
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department 760042
Colombia
Klinički bolnički centar Zagreb ( Site 3700)
Zagreb, City of Zagreb 10000
Croatia
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen, Capital Region DK-2100
Denmark
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere, Pirkanmaa 33520
Finland
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac, Aquitaine 33600
France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
Nantes, Loire-Atlantique 44093
France
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille, Nord 59037
France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
Marseille, Provence-Alpes-Côte d'Azur Region 13005
France
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
Paris, 75015
France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
Paris, 75019
France
Universitaetsklinikum Freiburg ( Site 1102)
Freiburg im Breisgau, Baden-Wurttemberg 79106
Germany
Universitaetsklinikum Heidelberg ( Site 1100)
Heidelberg, Baden-Wurttemberg 69120
Germany
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
Erlangen, Bavaria 91054
Germany
Medizinische Hochschule Hannover ( Site 1108)
Hanover, Lower Saxony 30625
Germany
Deutsches Herzzentrum Berlin ( Site 1101)
Berlin, 13353
Germany
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, 1096
Hungary
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, D12 N512
Ireland
IRCCS Istituto Giannina Gaslini ( Site 1603)
Genoa, Liguria 16147
Italy
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
Milan, Lombardy 20154
Italy
Ospedale Infantile Regina Margherita ( Site 1604)
Turin, Piedmont 10126
Italy
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
Rome, Roma 00165
Italy
A.O.Universitaria Meyer ( Site 1600)
Florence, Tuscany 50139
Italy
Azienda Ospedale - Università Padova ( Site 1601)
Padova, Veneto 35128
Italy
Hospital Universiti Sains Malaysia ( Site 1703)
Kota Bharu, Kelantan 16150
Malaysia
University Malaya Medical Centre ( Site 1701)
Lembah Pantai, Kuala Lumpur 59100
Malaysia
Hospital Queen Elizabeth II ( Site 1706)
Kota Kinabalu, Sabah Kota Kinab
Malaysia
Hospital Tunku Azizah-Paediatric ( Site 1700)
Kuala Lumpur, 50300
Malaysia
Institut Jantung Negara ( Site 1705)
Kuala Lumpur, 50400
Malaysia
Morales Vargas Centro de Investigacion ( Site 1810)
León, Guanajuato 37000
Mexico
CINVEC Medica ( Site 1814)
Guadalajara, Jalisco 44690
Mexico
Instituto Nacional de Pediatria ( Site 1803)
Mexico City, Mexico City 04530
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
Monterrey, Nuevo León 66460
Mexico
INVECORDIS S.C. ( Site 1808)
Hacienda de Las Palmas, State of Mexico 52763
Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
Ciudad Madero, Tamaulipas 89440
Mexico
Centro de Atención e Investigación Clínica ( Site 1813)
Aguascalientes, 20129
Mexico
UROLAP ( Site 1812)
Colima, 28000
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
México, 14080
Mexico
Erasmus Medisch Centrum ( Site 1900)
Rotterdam, South Holland 3015 CN
Netherlands
University Medical Center Groningen ( Site 1901)
Groningen, 9713 GZ
Netherlands
Universitair Medisch Centrum Utrecht ( Site 1902)
Utrecht, 3584 CX
Netherlands
Auckland City Hospital ( Site 2000)
Auckland, 1023
New Zealand
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
Jesús María, Lima 15072
Peru
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
Gdansk, Pomeranian Voivodeship 80-952
Poland
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon, Lisbon District 2790-134
Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
Lisbon, 1649-035
Portugal
Unidade Local de Saúde de São João ( Site 2403)
Porto, 4200-319
Portugal
Childrens University Hospital ( Site 4200)
Belgrade, Beograd 11000
Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
Belgrade, Beograd 11000
Serbia
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
Novi Sad, Vojvodina 21000
Serbia
National University Hospital-Paediatrics ( Site 2600)
Singapore, South West 119074
Singapore
KK Women's and Children's Hospital ( Site 2601)
Singapore, South West 229899
Singapore
TREAD Research ( Site 2700)
Cape Town, Western Cape 7500
South Africa
Children's Heart Disease Research Unit ( Site 2704)
Cape Town, Western Cape 7700
South Africa
Pusan National University Yangsan Hospital ( Site 2802)
Pusan, Kyongsangnam-do 50612
South Korea
Seoul National University Hospital ( Site 2803)
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System ( Site 2800)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 2801)
Seoul, 06351
South Korea
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat, Barcelona 08950
Spain
Hospital Universitari Vall d'Hebron ( Site 2903)
Barcelona, Catalonia 08035
Spain
Hospital Materno-Infantil Teresa Herrera ( Site 2905)
A Coruña, La Coruna 15009
Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid, Madrid, Comunidad de 28007
Spain
Hospital Universitario La Paz ( Site 2912)
Madrid, 28046
Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
Seville, 41013
Spain
Skånes Universitetssjukhus Lund ( Site 3000)
Lund, Skåne County 22185
Sweden
Astrid Lindgrens Barnsjukhus ( Site 3001)
Solna, Stockholm County 171 64
Sweden
Faculty of Medicine Siriraj Hospital ( Site 3200)
Bangkoknoi, Bangkok 10700
Thailand
Faculty of Medicine - Khon Kaen University ( Site 3202)
Muang, Changwat Khon Kaen 40002
Thailand
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, 50200
Thailand
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara, 06230
Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi ( Site 3301)
Ankara, 06490
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
Ankara, 06800
Turkey (Türkiye)
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
Istanbul, 34668
Turkey (Türkiye)
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir, 35210
Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
London, London, City of WC1N 3JH
United Kingdom
Freeman Hospital ( Site 3400)
Newcastle upon Tyne, NE7 7DN
United Kingdom