Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

April 5, 2024 updated by: Merck Sharp & Dohme LLC

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. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 093322441
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216343978
  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Incor - Instituto do Coracao ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: 5511998206862
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04012-909
        • Recruiting
        • Instituto Dante Pazzanese de Cardiology ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: 50856204
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Recruiting
        • Centre intégré universitaire de santé et de services sociaux-Centre de recherche du CHUS ( Site 0502
        • Contact:
          • Study Coordinator
          • Phone Number: 819-346-1110 ext 70454
  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Recruiting
        • Clinica Somer ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: 3125891661
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 8001
        • Recruiting
        • Ciensalud Ips S A S ( Site 0608)
        • Contact:
          • Study Coordinator
          • Phone Number: 3506961481
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: 3165212877
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 42406752
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: +358503539956
  • France
      • Paris, France, 75019
        • Recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
        • Contact:
          • Study Coordinator
          • Phone Number: 0140032189
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +33171396621
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 5 57623229
    • Nord
      • Lille Cedex, Nord, France, 59037
        • Recruiting
        • CHU Lille - Institut Coeur Poumon ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 0320445062
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10
        • Contact:
          • Study Coordinator
          • Phone Number: 0240087742
    • Provence-Alpes-Cote-d Azur
      • Marseille, Provence-Alpes-Cote-d Azur, France, 13005
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +334 91 38 67 50
  • Germany
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 076127043230
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 00496221564606
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • Kinderklinik des Uni-Klinikums Erlangen ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318533750
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: 05115326751
  • Hungary
      • Budapest, Hungary, 1096
        • Recruiting
        • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 703820305
  • Ireland
      • Dublin, Ireland, D12 N512
        • Recruiting
        • Children's Health Ireland (CHI) at Crumlin ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 01-4282854
  • Italy
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Recruiting
        • A.O.Universitaria Meyer ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: 0555662458
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2072-0266
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-10-8618-1798
    • Kyongsangnam-do
      • Busan, Kyongsangnam-do, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-10-4919-1313
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Recruiting
        • Institut Jantung Negara ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: 603-26178465
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0123500973
  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Recruiting
        • University Medical Center Groningen ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 31503612800
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 31 88 75 547
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 093670009
  • Portugal
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225512100
    • Lisboa
      • Lisbon, Lisboa, Portugal, 2790-134
        • Recruiting
        • Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +351210431000
      • Lisbon, Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +351213594332
  • Singapore
    • South West
      • Singapore, South West, Singapore, 119074
        • Recruiting
        • National University Hospital-Paediatrics ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: 67795555
      • Singapore, South West, Singapore, 229899
        • Recruiting
        • KK Women's and Children's Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 63941960
  • Spain
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: 932532100
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915290523
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, 22185
        • Recruiting
        • Skånes Universitetssjukhus Lund ( Site 3000)
        • Contact:
          • Study Coordinator
          • Phone Number: +4646171000
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: 66866731332
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: 043363012
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: 66815597331
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 3304)
        • Contact:
          • Study Coordinator
          • Phone Number: +905422151537
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: +905053166839
      • Izmir, Turkey, 35210
        • Recruiting
        • S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 532 516 80 22
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: 07899895040
    • London, City Of
      • London, London, City Of, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7405 9200
  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health System ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 909-558-5830
      • Los Angeles, California, United States, 90095
        • Recruiting
        • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-825-9111
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado ( Site 0012)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-777-1234
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-884-2327
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital ( Site 0029)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-898-7451
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-785-0381
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-678-4357
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • The Children's Hospital at Montefiore ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 718-741-2426
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-305-5437
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-2200
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia (CHOP) ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-590-1000
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-692-5325
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-287-5760
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-987-2015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a history of 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
  • 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 for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed

Exclusion Criteria:

  • Is clinically unstable-with at least one of the following: hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic or oral diuretic dose increase
  • 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
  • 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 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 concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vericiguat
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
Drug: Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Other Names:
  • MK-1242
Drug: Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Other Names:
  • MK-1242
Placebo Comparator: Placebo
Placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks
Drug: Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Other Names:
  • Placebo for MK-1242
Drug: Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
Other Names:
  • Placebo for MK-1242

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline and Week 16
Change from baseline to Week 16 in log-transformed NT-proBNP
Baseline and Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to Week 52 in log-transformed NT-proBNP
Time Frame: 1Baseline and Week 52
Change from baseline to Week 52 in log-transformed NT-proBNP
1Baseline and Week 52
First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
Time Frame: Up to Week 54
Time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization
Up to Week 54
Participants with one or more adverse events (AE)
Time Frame: Up to Week 54
Percentage of participants with one or more adverse events (AE)
Up to Week 54
Participants who discontinued study drug due to an AE
Time Frame: Up to Week 52
Percentage of participants who discontinued study drug due to an AE
Up to Week 52
Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Half-life (t1/2) of vericiguat in plasma
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
t1/2 of vericiguat in plasma
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Oral clearance (CL/F) of plasma vericiguat
Time Frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
CL/F of plasma vericiguat
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1242-036
  • MK-1242-036 (Other Identifier: Merck)
  • 2021-004399-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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