AzTrials
AzTrials

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 111 sites in 30 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
111 sitesin 30 countries
Study dates
31 May 2023to 12 May 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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.
Show all 19Show fewer
  • 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

111 sites in 30 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

111 sites in 30 countries

United States20 sites, 20 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

    Recruiting

Other trials in United States

Mexico9 sites, 9 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

    Recruiting

Other trials in Mexico

France6 sites

  • 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

    Completed

Other trials in France

Italy6 sites, 5 recruiting

  • A.O.Universitaria Meyer ( Site 1600)

    Florence, Tuscany, 50139

    Completed

  • 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

    Recruiting

Other trials in Italy

Spain6 sites, 5 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

    Completed

Other trials in Spain

Colombia5 sites, 5 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

    Recruiting

Other trials in Colombia

Germany5 sites, 4 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

    Recruiting

  • Universitaetsklinikum Heidelberg ( Site 1100)

    Heidelberg, Baden-Wurttemberg, 69120

    Completed

Other trials in Germany

Malaysia5 sites, 5 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

    Recruiting

Other trials in Malaysia

Turkey (Türkiye)5 sites, 3 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

    Completed

  • S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)

    Izmir, 35210

    Completed

Other trials in Turkey (Türkiye)

South Korea4 sites, 3 recruiting

  • Pusan National University Yangsan Hospital ( Site 2802)

    Pusan, Kyongsangnam-do, 50612

    Completed

  • 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

    Recruiting

Other trials in South Korea

Belgium3 sites, 2 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

    Active, not recruiting

Other trials in Belgium

Canada3 sites, 3 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

    Recruiting

Other trials in Canada

Netherlands3 sites, 3 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

    Recruiting

Other trials in Netherlands

Portugal3 sites

  • Unidade Local de Saude Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)

    Lisbon, Lisbon District, 2790-134

    Completed

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2402)

    Lisbon, 1649-035

    Completed

  • Unidade Local de Saúde de São João ( Site 2403)

    Porto, 4200-319

    Active, not recruiting

Other trials in Portugal

Saudi Arabia3 sites, 3 recruiting

  • King Abdullah International Medical Research Center ( Site 4145)

    Al Ahsa, Riyadh Region, 31982

    Study Coordinator, +966506920153

    Recruiting

  • King Abdul Aziz Medical City - AlRiyadh ( Site 4110)

    Riyadh, Riyadh Region, 11426

    Study Coordinator, +966112520088

    Recruiting

  • King Faisal Specialist Hospital and Research Center ( Site 4100)

    Riyadh, Riyadh Region, 12713

    Study Coordinator, +966114647272

    Recruiting

Other trials in Saudi Arabia

Serbia3 sites, 3 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

    Recruiting

Other trials in Serbia

Thailand3 sites, 2 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

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 3202)

    Muang, Changwat Khon Kaen, 40002

    Completed

Other trials in Thailand

Brazil2 sites, 2 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

    Recruiting

Other trials in Brazil

Peru2 sites, 1 recruiting

  • Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2100)

    Jesús María, Lima, 15072

    Completed

  • Instituto Nacional de Salud del Nino San Borja ( Site 2105)

    San Borja, Lima region, 15037

    Study Coordinator, +512300600

    Recruiting

Other trials in Peru

Singapore2 sites, 2 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

    Recruiting

Other trials in Singapore

South Africa2 sites, 1 recruiting

  • TREAD Research ( Site 2700)

    Cape Town, Western Cape, 7500

    Completed

  • Children's Heart Disease Research Unit ( Site 2704)

    Cape Town, Western Cape, 7700

    Study Coordinator, 076 844 4074.

    Recruiting

Other trials in South Africa

Sweden2 sites, 2 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

    Recruiting

Other trials in Sweden

United Kingdom2 sites, 2 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

    Recruiting

Other trials in United Kingdom

Croatia1 site, 1 recruiting

  • Klinički bolnički centar Zagreb ( Site 3700)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, 0038512367590

    Recruiting

Other trials in Croatia

Denmark1 site, 1 recruiting

  • Rigshospitalet-BørneUngeAfdelingen ( Site 0800)

    Copenhagen, Capital Region, DK-2100

    Study Coordinator, +45 35453545

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358503539956

    Recruiting

Other trials in Finland

Hungary1 site, 1 recruiting

  • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)

    Budapest, 1096

    Study Coordinator, +3612151220

    Recruiting

Other trials in Hungary

Ireland1 site, 1 recruiting

  • Children's Health Ireland (CHI) at Crumlin ( Site 1400)

    Dublin, D12 N512

    Study Coordinator, 01-4282854

    Recruiting

Other trials in Ireland

New Zealand1 site, 1 recruiting

  • Auckland City Hospital ( Site 2000)

    Auckland, 1023

    Study Coordinator, +6493670009

    Recruiting

Other trials in New Zealand

Poland1 site

  • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 2302)

    Gdansk, Pomeranian Voivodeship, 80-952

    Completed

Other trials in Poland

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 groups in NCT05714085
Study groupRoleWhat they receive
Base Period: VericiguatExperimentalParticipants 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: PlaceboPlacebo comparatorParticipants 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: VericiguatExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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.

  1. First posted6 Feb 2023
  2. Study start31 May 2023
  3. Primary completion20 Aug 2029 (estimated)
  4. Study completion12 May 2032 (estimated)

Resources

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)
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
Oct 2026
First submitted
26 Jan 2023
Last updated
30 Oct 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

Questions about this trial

What is this clinical trial studying?

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 111 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Mexico, France, Italy, Spain and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) (time frame: Baseline and Week 16 of Base Period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05714085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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