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

Primary Purpose

Heart Failure, Left Ventricular Systolic Dysfunction

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vericiguat tablet
Vericiguat suspension
Placebo tablet
Placebo suspension
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

29 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Health System ( Site 0008)Recruiting
  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)Recruiting
  • Children's Hospital Colorado ( Site 0012)Recruiting
  • Johns Hopkins All Children's Hospital ( Site 0029)Recruiting
  • Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001)Recruiting
  • Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)Recruiting
  • The Children's Hospital at Montefiore ( Site 0030)Recruiting
  • Columbia University Medical Center-Pediatric Cardiology ( Site 0016)Recruiting
  • Children's Hospital of Philadelphia (CHOP) ( Site 0004)Recruiting
  • Children's Hospital of Pittsburgh ( Site 0010)Recruiting
  • Le Bonheur Children's Hospital ( Site 0007)Recruiting
  • Clinica Somer ( Site 0607)Recruiting
  • Ciensalud Ips S A S ( Site 0608)Recruiting
  • Fundacion Valle del Lili- CIC ( Site 0604)Recruiting
  • Rigshospitalet-BørneUngeAfdelingen ( Site 0800)Recruiting
  • Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)Recruiting
  • CHU Bordeaux Haut-Leveque ( Site 1000)Recruiting
  • CHU Lille - Institut Coeur Poumon ( Site 1005)Recruiting
  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10Recruiting
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)Recruiting
  • Hôpital Universitaire Necker Enfants Malades ( Site 1001)Recruiting
  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo UniversitaRecruiting
  • Universitaetsklinikum Heidelberg ( Site 1100)Recruiting
  • Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)Recruiting
  • Children's Health Ireland (CHI) at Crumlin ( Site 1400)Recruiting
  • University Malaya Medical Centre ( Site 1701)Recruiting
  • Institut Jantung Negara ( Site 1705)Recruiting
  • University Medical Center Groningen ( Site 1901)Recruiting
  • Universitair Medisch Centrum Utrecht ( Site 1902)Recruiting
  • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402)Recruiting
  • Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)Recruiting
  • Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)Recruiting
  • National University Hospital-Paediatrics ( Site 2600)Recruiting
  • KK Women's and Children's Hospital ( Site 2601)Recruiting
  • Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)Recruiting
  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)Recruiting
  • Skånes Universitetssjukhus Lund ( Site 3000)Recruiting
  • Faculty of Medicine Siriraj Hospital ( Site 3200)Recruiting
  • Hacettepe Universite Hastaneleri ( Site 3304)Recruiting
  • Ankara Bilkent Şehir Hastanesi. ( Site 3300)Recruiting
  • S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vericiguat

Placebo

Arm Description

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

Placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks

Outcomes

Primary Outcome Measures

Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from baseline to Week 16 in log-transformed NT-proBNP

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2023
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05714085
Brief Title
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
April 30, 2030 (Anticipated)
Study Completion Date
April 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Ventricular Systolic Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Vericiguat tablet
Other Intervention Name(s)
MK-1242
Intervention Description
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Intervention Type
Drug
Intervention Name(s)
Vericiguat suspension
Other Intervention Name(s)
MK-1242
Intervention Description
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Other Intervention Name(s)
Placebo for MK-1242
Intervention Description
Placebo for vericiguat administered orally once daily in tablet form
Intervention Type
Drug
Intervention Name(s)
Placebo suspension
Other Intervention Name(s)
Placebo for MK-1242
Intervention Description
Placebo for vericiguat administered orally once daily in suspension form
Primary Outcome Measure Information:
Title
Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Description
Change from baseline to Week 16 in log-transformed NT-proBNP
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Change from baseline to Week 52 in log-transformed NT-proBNP
Description
Change from baseline to Week 52 in log-transformed NT-proBNP
Time Frame
1Baseline and Week 52
Title
First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
Description
Time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization
Time Frame
Up to Week 54
Title
Participants with one or more adverse events (AE)
Description
Percentage of participants with one or more adverse events (AE)
Time Frame
Up to Week 54
Title
Participants who discontinued study drug due to an AE
Description
Percentage of participants who discontinued study drug due to an AE
Time Frame
Up to Week 52
Title
Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Description
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
Title
Half-life (t1/2) of vericiguat in plasma
Description
t1/2 of vericiguat in plasma
Time Frame
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
Title
Oral clearance (CL/F) of plasma vericiguat
Description
CL/F of plasma vericiguat
Time Frame
Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University Health System ( Site 0008)
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-996-6640
Facility Name
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-825-9111
Facility Name
Children's Hospital Colorado ( Site 0012)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
720-777-1234
Facility Name
Johns Hopkins All Children's Hospital ( Site 0029)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
727-898-7451
Facility Name
Children's Healthcare of Atlanta - Egleston Hospital ( Site 0001)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
240-988-7742
Facility Name
Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-650-2205
Facility Name
The Children's Hospital at Montefiore ( Site 0030)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
718-741-2426
Facility Name
Columbia University Medical Center-Pediatric Cardiology ( Site 0016)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-305-5437
Facility Name
Children's Hospital of Philadelphia (CHOP) ( Site 0004)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-590-1000
Facility Name
Children's Hospital of Pittsburgh ( Site 0010)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-692-5325
Facility Name
Le Bonheur Children's Hospital ( Site 0007)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-276-9690
Facility Name
Clinica Somer ( Site 0607)
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054040
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3125891661
Facility Name
Ciensalud Ips S A S ( Site 0608)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
8001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3506961481
Facility Name
Fundacion Valle del Lili- CIC ( Site 0604)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3165212877
Facility Name
Rigshospitalet-BørneUngeAfdelingen ( Site 0800)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 42406752
Facility Name
Tampereen yliopistollinen sairaala-Pediatric Early Phase Trials Unit ( Site 0900)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358503539956
Facility Name
CHU Bordeaux Haut-Leveque ( Site 1000)
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33 5 57623229
Facility Name
CHU Lille - Institut Coeur Poumon ( Site 1005)
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0320445062
Facility Name
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 10
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0240087742
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1003)
City
Marseille
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+334 91 38 67 50
Facility Name
Hôpital Universitaire Necker Enfants Malades ( Site 1001)
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33171396621
Facility Name
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0140032189
Facility Name
Universitaetsklinikum Heidelberg ( Site 1100)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00496221564606
Facility Name
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
703820305
Facility Name
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
City
Dublin
ZIP/Postal Code
D12 N512
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01-4282854
Facility Name
University Malaya Medical Centre ( Site 1701)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0123500973
Facility Name
Institut Jantung Negara ( Site 1705)
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
603-26178465
Facility Name
University Medical Center Groningen ( Site 1901)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31503612800
Facility Name
Universitair Medisch Centrum Utrecht ( Site 1902)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31 88 75 547
Facility Name
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 2402)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351213594332
Facility Name
Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz ( Site 2401)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
2790-134
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210431000
Facility Name
Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 2403)
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225512100
Facility Name
National University Hospital-Paediatrics ( Site 2600)
City
Singapore
State/Province
South West
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
67795555
Facility Name
KK Women's and Children's Hospital ( Site 2601)
City
Singapore
State/Province
South West
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
63941960
Facility Name
Hospital Sant Joan de Déu-Pediatric cardiology ( Site 2902)
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
932532100
Facility Name
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2904)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34915290523
Facility Name
Skånes Universitetssjukhus Lund ( Site 3000)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4646171000
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 3200)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
66815597331
Facility Name
Hacettepe Universite Hastaneleri ( Site 3304)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905422151537
Facility Name
Ankara Bilkent Şehir Hastanesi. ( Site 3300)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905053166839
Facility Name
S.B.Ü. DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ ( Site 3303)
City
Izmir
ZIP/Postal Code
35210
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 532 516 80 22

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1242-036&kw=1242-036
Description
Plain Language Summary
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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