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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05714085
Registration number
NCT05714085
Ethics application status
Date submitted
26/01/2023
Date registered
6/02/2023
Date last updated
21/06/2024
Titles & IDs
Public title
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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Scientific 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)
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Secondary ID [1]
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MK-1242-036
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Secondary ID [2]
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1242-036
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Left Ventricular Systolic Dysfunction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vericiguat tablet
Treatment: Drugs - Vericiguat suspension
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Placebo suspension
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
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
Treatment: Drugs: Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Treatment: Drugs: Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Treatment: Drugs: Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
Treatment: Drugs: Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
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Assessment method [1]
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Change from baseline to Week 16 in log-transformed NT-proBNP
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Change from baseline to Week 52 in log-transformed NT-proBNP
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Assessment method [1]
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Change from baseline to Week 52 in log-transformed NT-proBNP
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Timepoint [1]
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1Baseline and Week 52
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Secondary outcome [2]
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First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
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Assessment method [2]
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Time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization
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Timepoint [2]
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Up to Week 54
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Secondary outcome [3]
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Participants with one or more adverse events (AE)
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Assessment method [3]
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Percentage of participants with one or more adverse events (AE)
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Timepoint [3]
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Up to Week 54
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Secondary outcome [4]
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Participants who discontinued study drug due to an AE
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Assessment method [4]
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Percentage of participants who discontinued study drug due to an AE
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Timepoint [4]
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Up to Week 52
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Secondary outcome [5]
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Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
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Assessment method [5]
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Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
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Timepoint [5]
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Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
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Secondary outcome [6]
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Half-life (t1/2) of vericiguat in plasma
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Assessment method [6]
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t1/2 of vericiguat in plasma
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Timepoint [6]
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Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
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Secondary outcome [7]
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Oral clearance (CL/F) of plasma vericiguat
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Assessment method [7]
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CL/F of plasma vericiguat
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Timepoint [7]
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Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose
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Eligibility
Key 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
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Minimum age
29
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2030
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Actual
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Sample size
Target
342
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Missouri
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New York
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Ohio
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Pennsylvania
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Tennessee
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Washington
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Belgium
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Liege
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams-Brabant
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Brazil
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Sao Paulo
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Alberta
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Valle Del Cauca
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Hovedstaden
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Pirkanmaa
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Aquitaine
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France
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Nord
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France
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Pays-de-la-Loire
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France
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Provence-Alpes-Cote-d Azur
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France
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Paris
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Germany
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Germany
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Bayern
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Germany
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Seoul
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Auckland
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Portugal
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Lisboa
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Spain
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Barcelona
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Spain
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Madrid, Comunidad De
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Sweden
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Skane Lan
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Thailand
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Khon Kaen
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Thailand
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Krung Thep Maha Nakhon
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Thailand
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Chiang Mai
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Ankara
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Izmir
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London, City Of
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United Kingdom
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05714085
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05714085
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