Heart FailurePhase 2/3NCT05714085
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
A Phase 2/3 study testing Vericiguat tablet and Vericiguat suspension in people with Heart Failure and Left Ventricular Systolic Dysfunction, run by Merck Sharp & Dohme LLC at 109 sites in 30 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 17 years
- Conditions the study is for
- Heart Failure, Left Ventricular Systolic Dysfunction
- What is being tested?
- Vericiguat tablet and Vericiguat suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 109 sitesin 30 countries
- Study dates
- 31 May 2023to 15 Apr 2032
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
109 sites in 30 countries. Contact the study team or a site near you to ask about taking part.
109 sites in 30 countries
United States20 sites, 20 recruiting
- Recruiting
C.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, 48109
Study Coordinator, 734-615-0590
- Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, 30329
Study Coordinator, 404-785-0381
- Recruiting
Children's Hospital Colorado ( Site 0012)
Aurora, Colorado, 80045
Study Coordinator, 720-777-1234
- Recruiting
Boston Children's Hospital ( Site 0035)
Boston, Massachusetts, 02115
Study Coordinator, 617-355-4213
- Recruiting
Cincinnati Children's Hospital Medical Center ( Site 0034)
Cincinnati, Ohio, 45229
Study Coordinator, 513-636-3016
- Recruiting
Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
Cleveland, Ohio, 44195
Study Coordinator, 216-444-2200
- Recruiting
Children's Health-The Heart Center ( Site 0015)
Dallas, Texas, 75235
Study Coordinator, 214-456-7000
- Recruiting
Texas Children's Hospital ( Site 0039)
Houston, Texas, 77030
Study Coordinator, 832-826-2806
- Recruiting
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, 90095
Study Coordinator, 310-825-9111
- Recruiting
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee, 38103
Study Coordinator, 901-287-5760
- Recruiting
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, 10032
Study Coordinator, 212-305-5437
- Recruiting
Lucile Packard Children's Hospital ( Site 0040)
Palo Alto, California, 94304
Study Coordinator, 650-721-2121
- Recruiting
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
Philadelphia, Pennsylvania, 19104
Study Coordinator, 215-590-1000
- Recruiting
Children's Hospital of Pittsburgh ( Site 0010)
Pittsburgh, Pennsylvania, 15224
Study Coordinator, 412-692-5325
- Recruiting
Loma Linda University Health System ( Site 0008)
San Bernardino, California, 92408
Study Coordinator, 909-558-5830
- Recruiting
Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
Seattle, Washington, 98105
Study Coordinator, 206-987-2015
- Recruiting
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, 63110
Study Coordinator, 800-678-4357
- Recruiting
Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, 33701
Study Coordinator, 727-898-7451
- Recruiting
The Children's Hospital at Montefiore ( Site 0030)
The Bronx, New York, 10467
Study Coordinator, 718-741-2426
- Recruiting
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, 20010
Study Coordinator, 888-884-2327
Mexico9 sites, 9 recruiting
- Recruiting
Centro de Atención e Investigación Clínica ( Site 1813)
Aguascalientes, 20129
Study Coordinator, +525543673716
- Recruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1800)
Ciudad Madero, Tamaulipas, 89440
Study Coordinator, +528331260055
- Recruiting
UROLAP ( Site 1812)
Colima, 28000
Study Coordinator, +523121552653
- Recruiting
CINVEC Medica ( Site 1814)
Guadalajara, Jalisco, 44690
Study Coordinator, +523338012160
- Recruiting
INVECORDIS S.C. ( Site 1808)
Hacienda de Las Palmas, State of Mexico, 52763
Study Coordinator, 5552469710
- Recruiting
Morales Vargas Centro de Investigacion S. C. ( Site 1810)
León, Guanajuato, 37000
Study Coordinator, +524777160714
- Recruiting
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 1804)
México, 14080
Study Coordinator, +525520917905
- Recruiting
Instituto Nacional de Pediatria ( Site 1803)
Mexico City, Mexico City, 04530
Study Coordinator, +525556069738
- Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Pediatria ( Site 1816)
Monterrey, Nuevo León, 66460
Study Coordinator, +528183486173
France6 sites
- Completed
CHU Lille - Institut Coeur Poumon ( Site 1005)
Lille, Nord, 59037
- Completed
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
- Completed
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1002)
Nantes, Loire-Atlantique, 44093
- Completed
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
Paris, 75015
- Completed
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita ( Site 1004)
Paris, 75019
- Completed
CHU Bordeaux Haut-Leveque ( Site 1000)
Pessac, Aquitaine, 33600
Italy6 sites, 5 recruiting
- Completed
A.O.Universitaria Meyer ( Site 1600)
Florence, Tuscany, 50139
- Recruiting
IRCCS Istituto Giannina Gaslini ( Site 1603)
Genoa, Liguria, 16147
Study Coordinator, +3901056363993
- Recruiting
Ospedale dei Bambini "Vittore Buzzi" ( Site 1606)
Milan, Lombardy, 20154
Study Coordinator, +390263635733
- Recruiting
Azienda Ospedale - Università Padova ( Site 1601)
Padova, Veneto, 35128
Study Coordinator, 0498213558
- Recruiting
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 1602)
Rome, Roma, 00165
Study Coordinator, +390668592217
- Recruiting
Ospedale Infantile Regina Margherita ( Site 1604)
Turin, Piedmont, 10126
Study Coordinator, +390113131853
Spain6 sites, 6 recruiting
- Recruiting
Hospital Materno-Infantil Teresa Herrera ( Site 2905)
A Coruña, La Coruna, 15009
Study Coordinator, 0034689979147
- Recruiting
Hospital Universitari Vall d'Hebron ( Site 2903)
Barcelona, Catalonia, 08035
Study Coordinator, 934893135
- Recruiting
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
Esplugues de Llobregat, Barcelona, 08950
Study Coordinator, +34 932532100
- Recruiting
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
Madrid, Madrid, Comunidad de, 28007
Study Coordinator, +34915290523
- Recruiting
Hospital Universitario La Paz ( Site 2912)
Madrid, 28046
Study Coordinator, +34638372829
- Recruiting
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2907)
Seville, 41013
Study Coordinator, +34669896556
Colombia5 sites, 5 recruiting
- Recruiting
Ciensalud Ips S A S ( Site 0608)
Barranquilla, Atlántico, 08001
Study Coordinator, +573506961481
- Recruiting
Fundación Cardioinfantil Instituto de Cardiología ( Site 0603)
Bogotá, Bogota D.C., 110131
Study Coordinator, 6017563426 EXT 73205
- Recruiting
Fundación Valle del Lili ( Site 0604)
Cali, Valle del Cauca Department, 760032
Study Coordinator, +573133288646
- Recruiting
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department, 760042
Study Coordinator, +573117441693
- Recruiting
Clinica Somer ( Site 0607)
Rionegro, Antioquia, 054040
Study Coordinator, 57 3125891661
Germany5 sites, 4 recruiting
- Recruiting
Deutsches Herzzentrum Berlin ( Site 1101)
Berlin, 13353
Study Coordinator, + 49 30 4593 - 1000
- Recruiting
Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
Erlangen, Bavaria, 91054
Study Coordinator, +4991318533750
- Recruiting
Universitaetsklinikum Freiburg ( Site 1102)
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study Coordinator, +4976127043230
- Recruiting
Medizinische Hochschule Hannover ( Site 1108)
Hanover, Lower Saxony, 30625
Study Coordinator, +495115320
- Completed
Universitaetsklinikum Heidelberg ( Site 1100)
Heidelberg, Baden-Wurttemberg, 69120
Malaysia5 sites, 5 recruiting
- Recruiting
Hospital Universiti Sains Malaysia ( Site 1703)
Kota Bharu, Kelantan, 16150
Study Coordinator, +6097673000
- Recruiting
Hospital Queen Elizabeth II ( Site 1706)
Kota Kinabalu, Sabah, Kota Kinab
Study Coordinator, +6088324600
- Recruiting
Hospital Tunku Azizah-Paediatric ( Site 1700)
Kuala Lumpur, 50300
Study Coordinator, +60326003000
- Recruiting
Institut Jantung Negara ( Site 1705)
Kuala Lumpur, 50400
Study Coordinator, 603-26178465
- Recruiting
University Malaya Medical Centre ( Site 1701)
Lembah Pantai, Kuala Lumpur, 59100
Study Coordinator, +60479492351
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Hacettepe Universite Hastaneleri ( Site 3304)
Ankara, 06230
Study Coordinator, +90 (0312) 305 25 85
- Recruiting
Baskent Universitesi Ankara Hastanesi ( Site 3301)
Ankara, 06490
Study Coordinator, +90 (312) 246 66 66
- Recruiting
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
Ankara, 06800
Study Coordinator, +90 312 552 60 00
- Recruiting
Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 3302)
Istanbul, 34668
Study Coordinator, +90 216 542 44 44
- Recruiting
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
Izmir, 35210
Study Coordinator, +90 232 411 60 00
South Korea4 sites, 4 recruiting
- Recruiting
Pusan National University Yangsan Hospital ( Site 2802)
Pusan, Kyongsangnam-do, 50612
Study Coordinator, +82553603600
- Recruiting
Seoul National University Hospital ( Site 2803)
Seoul, 03080
Study Coordinator, 82220720266
- Recruiting
Severance Hospital, Yonsei University Health System ( Site 2800)
Seoul, 03722
Study Coordinator, 82222288470
- Recruiting
Samsung Medical Center ( Site 2801)
Seoul, 06351
Study Coordinator, +82234103538
Belgium3 sites, 3 recruiting
- Recruiting
UZ Gent ( Site 0301)
Ghent, Oost-Vlaanderen, 9000
Study Coordinator, +32 9 332 24 30
- Recruiting
UZ Leuven ( Site 0300)
Leuven, Vlaams-Brabant, 3000
Study Coordinator, +32 16 34 59 98
- Recruiting
Centre Hospitalier Régional de la Citadelle ( Site 0302)
Liège, Liege, 4000
Study Coordinator, +32 (0)4 321 89 77
Canada3 sites, 3 recruiting
- Recruiting
Stollery Children's Hospital ( Site 0501)
Edmonton, Alberta, T6G 2B7
Study Coordinator, 780-407-1586
- Recruiting
Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502)
Sherbrooke, Quebec, J1H 5H4
Study Coordinator, 819-346-1110, 12889
- Recruiting
The Hospital for Sick Children ( Site 0500)
Toronto, Ontario, M5G 1X8
Study Coordinator, 416-813-1500
Netherlands3 sites, 3 recruiting
- Recruiting
University Medical Center Groningen ( Site 1901)
Groningen, 9713 GZ
Study Coordinator, 31503612800
- Recruiting
Erasmus Medisch Centrum ( Site 1900)
Rotterdam, South Holland, 3015 CN
Study Coordinator, 0031650162663
- Recruiting
Universitair Medisch Centrum Utrecht ( Site 1902)
Utrecht, 3584 CX
Study Coordinator, 31 88 75 547
Portugal3 sites, 3 recruiting
- Recruiting
Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
Lisbon, Lisbon District, 2790-134
Study Coordinator, +351210431000
- Recruiting
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)
Lisbon, 1649-035
Study Coordinator, +351213594332
- Recruiting
Unidade Local de Saúde de São João ( Site 2403)
Porto, 4200-319
Study Coordinator, +351225512100
Serbia3 sites, 3 recruiting
- Recruiting
Childrens University Hospital ( Site 4200)
Belgrade, Beograd, 11000
Study Coordinator, +381641212915
- Recruiting
Institut za zdravstvenu zastitu majke i deteta Srbije ( Site 4220)
Belgrade, Beograd, 11000
Study Coordinator, +381658405885
- Recruiting
Institute for Child and Youth Helth Care of Vojvodina ( Site 4210)
Novi Sad, Vojvodina, 21000
Study Coordinator, +381642115233
Thailand3 sites, 2 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 3200)
Bangkoknoi, Bangkok, 10700
Study Coordinator, +6624197000
- Recruiting
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, 50200
Study Coordinator, +66834739974
- Completed
Faculty of Medicine - Khon Kaen University ( Site 3202)
Muang, Changwat Khon Kaen, 40002
Brazil2 sites, 2 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiology ( Site 0402)
São Paulo, São Paulo, 04012-909
Study Coordinator, 55 11 5085 6866
- Recruiting
Incor - Instituto do Coracao ( Site 0400)
São Paulo, 05403-900
Study Coordinator, +55 11 2661 5450
Peru2 sites, 1 recruiting
- Completed
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)
Jesús María, Lima, 15072
- Recruiting
Instituto Nacional de Salud del Nino San Borja ( Site 2105)
San Borja, Lima region, 15037
Study Coordinator, +512300600
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital-Paediatrics ( Site 2600)
Singapore, South West, 119074
Study Coordinator, 67795555
- Recruiting
KK Women's and Children's Hospital ( Site 2601)
Singapore, South West, 229899
Study Coordinator, 63941960
South Africa2 sites, 1 recruiting
- Completed
TREAD Research ( Site 2700)
Cape Town, Western Cape, 7500
- Recruiting
Children's Heart Disease Research Unit ( Site 2704)
Cape Town, Western Cape, 7700
Study Coordinator, 076 844 4074.
Sweden2 sites, 2 recruiting
- Recruiting
Skånes Universitetssjukhus Lund ( Site 3000)
Lund, Skåne County, 22185
Study Coordinator, +4646171000
- Recruiting
Astrid Lindgrens Barnsjukhus ( Site 3001)
Solna, Stockholm County, 171 64
Study Coordinator, +46812373124
United Kingdom2 sites, 2 recruiting
- Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
London, London, City of, WC1N 3JH
Study Coordinator, 020 7405 9200
- Recruiting
Freeman Hospital ( Site 3400)
Newcastle upon Tyne, NE7 7DN
Study Coordinator, 07899895040
Croatia1 site, 1 recruiting
- Recruiting
Klinički bolnički centar Zagreb ( Site 3700)
Zagreb, City of Zagreb, 10000
Study Coordinator, 0038512367590
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
Copenhagen, Capital Region, DK-2100
Study Coordinator, +45 35453545
Finland1 site, 1 recruiting
- Recruiting
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
Tampere, Pirkanmaa, 33520
Study Coordinator, +358503539956
Hungary1 site, 1 recruiting
- Recruiting
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, 1096
Study Coordinator, +3612151220
Ireland1 site, 1 recruiting
- Recruiting
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, D12 N512
Study Coordinator, 01-4282854
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital ( Site 2000)
Auckland, 1023
Study Coordinator, +6493670009
Poland1 site
- Completed
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)
Gdansk, Pomeranian Voivodeship, 80-952
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital and Research Center ( Site 4100)
Riyadh, Riyadh Region, 12713
Study Coordinator, +966114647272
About this study
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)
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.
Read the 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.
- Being tested
- Vericiguat tablet, Vericiguat suspension, Placebo tablet, Placebo suspension
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat tabletDrug
Also called MK-1242
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspensionDrug
Also called MK-1242
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tabletDrug
Also called Placebo for MK-1242
Placebo for vericiguat administered orally once daily in tablet form
Placebo suspensionDrug
Also called Placebo for MK-1242
Placebo for vericiguat administered orally once daily in suspension form
| Study group | Role | What they receive |
|---|---|---|
| Base Period: Vericiguat | Experimental | Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks. Receives: Drug: Vericiguat tablet; Drug: Vericiguat suspension |
| Base Period: Placebo | Placebo comparator | Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks. Receives: Drug: Placebo tablet; Drug: Placebo suspension |
| Extension Period: Vericiguat | Experimental | Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period. Receives: Drug: Vericiguat tablet; Drug: Vericiguat suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Measured: Baseline and Week 16 of Base Period
Extension Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.
Measured: Includes data collected up to a maximum of approximately 8 years
Extension Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Measured: Includes data collected up to a maximum of approximately 8 years
Secondary outcomes (8)
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP
The change from baseline to Week 52 of the Base Period in log-transformed NT-proBNP will be reported.
Measured: Baseline and Week 52 of Base Period
Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
The time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization will be reported for the Base Period.
Measured: Up to Week 54 of Base Period
Base Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Base Period will be reported.
Measured: Up to Week 54 of Base Period
Base Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Base Period due to an AE will be reported.
Measured: Up to Week 52 of Base Period
Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat.
Measured: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Half-life (t1/2) of vericiguat in plasma
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the t1/2 of vericiguat in plasma.
Measured: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Oral clearance (CL/F) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the CL/F of vericiguat in plasma.
Measured: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP
The change from the Extension Period baseline to Week 16 of the Extension Period in log-transformed NT-proBNP will be reported.
Measured: Extension Period Baseline (Study Week 54) and Extension Period Week 16 (Study Week 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start31 May 2023
- Primary completion15 Apr 2032 (estimated)
- Study completion15 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714085
- Sponsor's protocol ID
- 1242-036
- Other IDs
- MK-1242-036, 2022-501238-52-00, U1111-1275-1768, MK-1242-043, 2021-004399-33
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Fritsch A, Meyer M, Blaustein RO, Trujillo ME, Kauh E, Roessig L, Boettcher M, Becker C. Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat. Clin Pharmacokinet. 2024 Jun;63(6):751-771. doi: 10.1007/s40262-024-01384-1. Epub 2024 Jun 25.
PubMed 38916717