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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02861534
Registration number
NCT02861534
Ethics application status
Date submitted
5/08/2016
Date registered
10/08/2016
Date last updated
15/11/2021
Titles & IDs
Public title
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
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Scientific title
A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT GlObal Study in Subjects With Heart Failure With Reduced EjectIon FrAction (VICTORIA)
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Secondary ID [1]
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2016-000671-25
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Secondary ID [2]
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1242-001
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Universal Trial Number (UTN)
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Trial acronym
VICTORIA
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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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Chronic Heart Failure With Reduced Ejection Fraction
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vericiguat
Treatment: Drugs - Placebo for vericiguat
Experimental: Vericiguat - Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose will be uptitrated to 5 mg and to 10 mg.
Placebo Comparator: Placebo - Participants receive a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose will be uptitrated to 5 mg and to 10 mg.
Treatment: Drugs: Vericiguat
2.5, 5.0, or 10.0 mg orally once daily
Treatment: Drugs: Placebo for vericiguat
2.5, 5.0, or 10.0 mg orally once daily
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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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Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
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Assessment method [1]
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Time to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
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Timepoint [1]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [1]
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Time to the First Occurrence of CV Death
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Assessment method [1]
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Time to First Occurrence of CV Death was analyzed using a one-sided stratified log-rank test. Randomized participants without a CV death at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
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Timepoint [1]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [2]
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Time to the First Occurrence of HF Hospitalization
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Assessment method [2]
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Time to the First Occurrence of HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
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Timepoint [2]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [3]
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Time to Total HF Hospitalizations (Including First and Recurrent Events)
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Assessment method [3]
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Time to Total HF Hospitalizations (including first and recurring) was analyzed using an Andersen-Gill model. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years of follow-up) is provided.
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Timepoint [3]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [4]
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Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
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Assessment method [4]
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Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event or HF hospitalization at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
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Timepoint [4]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [5]
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Time to All-Cause Mortality
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Assessment method [5]
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Time to All-Cause Mortality was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results: the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
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Timepoint [5]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [6]
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Number of Participants Who Experienced One or More Adverse Events
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Assessment method [6]
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An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
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Timepoint [6]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [7]
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Number of Participants Who Discontinued Treatment Due to an Adverse Event
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Assessment method [7]
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An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
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Timepoint [7]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [8]
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Percentage of Participants Who Experienced Symptomatic Hypotension
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Assessment method [8]
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Study participants were monitored for symptomatic hypotension, an event of clinical interest, and results were reported.
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Timepoint [8]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Secondary outcome [9]
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Percentage of Participants Who Experienced Syncope
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Assessment method [9]
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Study participants were monitored for syncope, an event of clinical interest, and results were reported.
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Timepoint [9]
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Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
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Eligibility
Key inclusion criteria
- History of chronic HF (New York Heart Association [NYHA] Class II-IV) on standard
therapy before qualifying HF decompensation
- Previous HF hospitalization within 6 months prior to randomization or intravenous (IV)
diuretic treatment for HF (without hospitalization) within 3 months.
- Brain natriuretic peptide (BNP) levels: sinus rhythm-= 300 pg/mL; atrial
fibrillation-= 500 pg/mL and N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)
levels: sinus rhythm- = 1000 pg/mL; atrial fibrillation - = 1600 pg/mL within 30 days
prior to randomization
- Left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to
randomization by any method
- If female, is not of reproductive potential or agrees to avoid becoming pregnant while
receiving study drug and for 14 days after the last dose of study drug by complying
with one of the following: practice abstinence from heterosexual activity or use (or
have her partner use) acceptable contraception during heterosexual activity.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Clinically unstable at the time of randomization as defined by either the
administration of any IV treatment within 24 hours prior to randomization, and/or
systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension
- Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors
including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol
tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine
- Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as
vardenafil, tadalafil, and sildenafil
- Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as
riociguat
- Known allergy or sensitivity to any sGC stimulator
- Awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or
equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates
receiving an implanted ventricular assist device
- Primary valvular heart disease requiring surgery or intervention, or is within 3
months after valvular surgery or intervention
- Hypertrophic obstructive cardiomyopathy
- Acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy
- Post-heart transplant cardiomyopathy
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia
- Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction
[NSTEMI], or ST elevation myocardial infarction [(STEMI]) or coronary
revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary
intervention [PCI]) within 60 days, or indication for coronary revascularization at
time of randomization
- Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days
- Complex congenital heart disease
- Active endocarditis or constrictive pericarditis
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis
- Severe hepatic insufficiency such as with hepatic encephalopathy
- Malignancy or other non-cardiac condition limiting life expectancy to <3 years
- Require continuous home oxygen for severe pulmonary disease
- Current alcohol and/or drug abuse
- Participated in another interventional clinical study and treatment with another
investigational product =30 days prior to randomization or plans to participate in any
other trial/investigation during the duration of this study
- Mental or legal incapacitation and is unable to provide informed consent
- Immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is
involved with this study
- Interstitial Lung Disease
- Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the
course of the study
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
20/09/2016
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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
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Actual
2/09/2019
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Sample size
Target
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Accrual to date
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Final
5050
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Recruitment in Australia
Recruitment state(s)
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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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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bayer
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian VIGOUR Centre
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Duke Clinical Research Institute
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event
driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection
fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in
increasing the time to first occurrence of the composite of cardiovascular (CV) death or
heart failure (HF) hospitalization in participants with HFrEF.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02861534
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Mahesh J. Patel, MD
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02861534
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