Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat.
Achim Fritsch, Michaela Meyer, Robert O Blaustein...
https://pubmed.ncbi.nlm.nih.gov/38916717Actively Recruiting
Phase 2
Phase 3
Age: 29Days - 17Years
All Genders
ID05714085
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
342
Participants Needed
106
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of vericiguat compared to a placebo in children and teenagers with heart failure caused by left ventricular systolic dysfunction. This study aims to determine if vericiguat is better than placebo at reducing a heart failure marker called NT-proBNP over 16 weeks. The trial includes both a base period and an optional open-label extension phase to further assess safety and effectiveness. During the base period, participants receive either vericiguat or placebo once daily in tablet or suspension form for 52 weeks. Doses of vericiguat range from 2.5 mg to 10 mg in tablets or 0.2 mg/mL to 1 mg/mL in suspension. Participants who complete the base period and meet criteria may continue into an extension period where they receive vericiguat daily. The extension phase allows long-term monitoring of safety and effects. Participants will have blood tests to measure NT-proBNP levels at baseline, Week 16, Week 52, and during the extension period. Researchers will monitor adverse events, heart failure hospitalizations, and drug levels in the blood. Safety follow-up and assessments continue for up to about 8 years in the extension phase. The study lasts from the start through the extension period to capture long-term data on vericiguat's impact in pediatric heart failure.
CONDITIONS
Brief Title
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Who Can Participate
Age: 29Days - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Has symptomatic chronic heart failure resulting from systemic left ventricular systolic dysfunction
- Has biventricular physiology with a morphologic systemic left ventricle
- Is currently receiving stable medical therapy for heart failure
- Has left ventricular ejection fraction less than 45% assessed within 3 months before randomization
- Is of any sex/gender, aged over 28 days to under 18 years inclusive
- Weighs at least 3 kilograms
- Female participants must not be pregnant or breastfeeding and meet specific contraceptive or reproductive criteria
- For Extension Period: completed the Week 52 visit and safety follow-up period of the Base Period without permanently discontinuing study intervention
You will not qualify if you...
- Is clinically unstable, including symptomatic hypotension, recent intravenous inotrope or vasodilator use, or recent intravenous diuretic
- Has allergy or sensitivity to vericiguat or any soluble guanylate cyclase stimulator
- Has single ventricle heart disease or morphologic systemic right ventricle
- Has undergone or is awaiting heart transplantation or has an implanted ventricular assist device
- Has sustained or symptomatic uncontrolled dysrhythmia
- Has had recent cardiovascular surgery or interventions for congenital cardiac malformations
- Has unoperated or residual significant congenital cardiac malformations
- Has hypertrophic or restrictive cardiomyopathy
- Has active or recent myocarditis
- Has acute coronary syndrome or recent coronary intervention
- Has symptomatic carotid stenosis or cerebrovascular disease
- Has severe pulmonary hypertension
- Requires continuous home oxygen or has known interstitial lung disease
- Has severe chronic kidney disease
- Has hepatic disorders such as encephalopathy or Child Pugh Class C
- Has gastrointestinal or biliary disorders affecting medication absorption
- Has significant bone disease affecting bone formation
- Uses phosphodiesterase type 5 inhibitors or another sGC stimulator concurrently or anticipated
- Received COVID-19 vaccination within 1 week before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 52 weeks
Participants receive vericiguat or placebo orally once daily in tablet or suspension form for heart failure treatment.
Regular visits during 52 weeks for dosing and assessments
Extension Period
Duration - Up to approximately 8 years
Participants who complete the Base Period may join the optional open-label Extension Period to continue receiving vericiguat and have long-term safety and efficacy monitored.
Visits as scheduled during the extension period for treatment and safety monitoring
Trial Site Locations
Total: 106 locations
1
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, United States, 90095
Actively Recruiting
2
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California, United States, 94304
Actively Recruiting
3
Loma Linda University Health System ( Site 0008)
San Bernardino, California, United States, 92408
Actively Recruiting
4
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, United States, 33701
Actively Recruiting
7
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, United States, 10032
Actively Recruiting
12
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York, United States, 10467
Actively Recruiting
13
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
14
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
17
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee, United States, 38103
Actively Recruiting
18
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas, United States, 75235
Actively Recruiting
19
Texas Children's Hospital ( Site 0039)
Houston, Texas, United States, 77030
Actively Recruiting
20
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, United States, 98105
Actively Recruiting
21
Centre Hospitalier Régional de la Citadelle ( Site 0302)
Liège, Liege, Belgium, 4000
Actively Recruiting
22
UZ Gent ( Site 0301)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
23
UZ Leuven ( Site 0300)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
24
Instituto Dante Pazzanese de Cardiology ( Site 0402)
São Paulo, São Paulo, Brazil, 04012-909
Actively Recruiting
25
Incor - Instituto do Coracao ( Site 0400)
São Paulo, Brazil, 05403-900
Actively Recruiting
26
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
27
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec, Canada, J1H 5H4
Actively Recruiting
28
Clinica Somer ( Site 0607)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
29
Ciensalud Ips S A S ( Site 0608)
Barranquilla, Atlántico, Colombia, 08001
Actively Recruiting
30
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
Bogotá, Bogota D.C., Colombia, 110131
Actively Recruiting
31
Fundación Valle del Lili ( Site 0604)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
32
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department, Colombia, 760042
Actively Recruiting
33
Klinički bolnički centar Zagreb ( Site 3700)
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
34
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen, Capital Region, Denmark, DK-2100
Actively Recruiting
35
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
36
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac, Aquitaine, France, 33600
Completed
37
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
Nantes, Loire-Atlantique, France, 44093
Completed
38
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille, Nord, France, 59037
Completed
39
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Completed
40
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
Paris, France, 75015
Completed
41
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
Paris, France, 75019
Completed
42
Universitaetsklinikum Freiburg ( Site 1102)
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
43
Universitaetsklinikum Heidelberg ( Site 1100)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Completed
44
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
45
Medizinische Hochschule Hannover ( Site 1108)
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
46
Deutsches Herzzentrum Berlin ( Site 1101)
Berlin, Germany, 13353
Actively Recruiting
47
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, Hungary, 1096
Actively Recruiting
48
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, Ireland, D12 N512
Actively Recruiting
49
IRCCS Istituto Giannina Gaslini ( Site 1603)
Genoa, Liguria, Italy, 16147
Actively Recruiting
50
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
Milan, Lombardy, Italy, 20154
Actively Recruiting
51
Ospedale Infantile Regina Margherita ( Site 1604)
Turin, Piedmont, Italy, 10126
Actively Recruiting
52
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
Rome, Roma, Italy, 00165
Actively Recruiting
53
A.O.Universitaria Meyer ( Site 1600)
Florence, Tuscany, Italy, 50139
Completed
54
Azienda Ospedale - Università Padova ( Site 1601)
Padova, Veneto, Italy, 35128
Actively Recruiting
55
Hospital Universiti Sains Malaysia ( Site 1703)
Kota Bharu, Kelantan, Malaysia, 16150
Actively Recruiting
56
University Malaya Medical Centre ( Site 1701)
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
57
Hospital Queen Elizabeth II ( Site 1706)
Kota Kinabalu, Sabah, Malaysia, Kota Kinab
Actively Recruiting
58
Hospital Tunku Azizah-Paediatric ( Site 1700)
Kuala Lumpur, Malaysia, 50300
Actively Recruiting
59
Institut Jantung Negara ( Site 1705)
Kuala Lumpur, Malaysia, 50400
Actively Recruiting
60
Morales Vargas Centro de Investigacion ( Site 1810)
León, Guanajuato, Mexico, 37000
Actively Recruiting
61
CINVEC Medica ( Site 1814)
Guadalajara, Jalisco, Mexico, 44690
Actively Recruiting
62
Instituto Nacional de Pediatria ( Site 1803)
Mexico City, Mexico City, Mexico, 04530
Actively Recruiting
63
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
Monterrey, Nuevo León, Mexico, 66460
Actively Recruiting
64
INVECORDIS S.C. ( Site 1808)
Hacienda de Las Palmas, State of Mexico, Mexico, 52763
Actively Recruiting
65
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
Ciudad Madero, Tamaulipas, Mexico, 89440
Actively Recruiting
66
Centro de Atención e Investigación Clínica ( Site 1813)
Aguascalientes, Mexico, 20129
Actively Recruiting
67
UROLAP ( Site 1812)
Colima, Mexico, 28000
Actively Recruiting
68
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
México, Mexico, 14080
Actively Recruiting
69
Erasmus Medisch Centrum ( Site 1900)
Rotterdam, South Holland, Netherlands, 3015 CN
Actively Recruiting
70
University Medical Center Groningen ( Site 1901)
Groningen, Netherlands, 9713 GZ
Actively Recruiting
71
Universitair Medisch Centrum Utrecht ( Site 1902)
Utrecht, Netherlands, 3584 CX
Actively Recruiting
72
Auckland City Hospital ( Site 2000)
Auckland, New Zealand, 1023
Actively Recruiting
73
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
Jesús María, Lima, Peru, 15072
Actively Recruiting
74
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Completed
75
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon, Lisbon District, Portugal, 2790-134
Actively Recruiting
76
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
Lisbon, Portugal, 1649-035
Actively Recruiting
77
Unidade Local de Saúde de São João ( Site 2403)
Porto, Portugal, 4200-319
Actively Recruiting
78
Childrens University Hospital ( Site 4200)
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
79
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
80
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
Novi Sad, Vojvodina, Serbia, 21000
Actively Recruiting
81
National University Hospital-Paediatrics ( Site 2600)
Singapore, South West, Singapore, 119074
Actively Recruiting
82
KK Women's and Children's Hospital ( Site 2601)
Singapore, South West, Singapore, 229899
Actively Recruiting
83
TREAD Research ( Site 2700)
Cape Town, Western Cape, South Africa, 7500
Active, Not Recruiting
84
Children's Heart Disease Research Unit ( Site 2704)
Cape Town, Western Cape, South Africa, 7700
Actively Recruiting
85
Pusan National University Yangsan Hospital ( Site 2802)
Pusan, Kyongsangnam-do, South Korea, 50612
Actively Recruiting
86
Seoul National University Hospital ( Site 2803)
Seoul, South Korea, 03080
Actively Recruiting
87
Severance Hospital, Yonsei University Health System ( Site 2800)
Seoul, South Korea, 03722
Actively Recruiting
88
Samsung Medical Center ( Site 2801)
Seoul, South Korea, 06351
Actively Recruiting
89
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
90
Hospital Universitari Vall d'Hebron ( Site 2903)
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
91
Hospital Materno-Infantil Teresa Herrera ( Site 2905)
A Coruña, La Coruna, Spain, 15009
Actively Recruiting
92
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid, Madrid, Comunidad de, Spain, 28007
Actively Recruiting
93
Hospital Universitario La Paz ( Site 2912)
Madrid, Spain, 28046
Actively Recruiting
94
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
Seville, Spain, 41013
Actively Recruiting
95
Skånes Universitetssjukhus Lund ( Site 3000)
Lund, Skåne County, Sweden, 22185
Actively Recruiting
96
Astrid Lindgrens Barnsjukhus ( Site 3001)
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
97
Faculty of Medicine Siriraj Hospital ( Site 3200)
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
98
Faculty of Medicine - Khon Kaen University ( Site 3202)
Muang, Changwat Khon Kaen, Thailand, 40002
Completed
99
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, Thailand, 50200
Actively Recruiting
100
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
101
Baskent Universitesi Ankara Hastanesi ( Site 3301)
Ankara, Turkey (Türkiye), 06490
Actively Recruiting
102
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
103
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
Istanbul, Turkey (Türkiye), 34668
Actively Recruiting
104
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir, Turkey (Türkiye), 35210
Actively Recruiting
105
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom, WC1N 3JH
Actively Recruiting
106
Freeman Hospital ( Site 3400)
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
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Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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