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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02861534




Registration number
NCT02861534
Ethics application status
Date submitted
5/08/2016
Date registered
10/08/2016

Titles & IDs
Public title
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
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)
Secondary ID [1] 0 0
2016-000671-25
Secondary ID [2] 0 0
1242-001
Universal Trial Number (UTN)
Trial acronym
VICTORIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Chronic Heart Failure With Reduced Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Timepoint [1] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [1] 0 0
Time to the First Occurrence of CV Death
Timepoint [1] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [2] 0 0
Time to the First Occurrence of HF Hospitalization
Timepoint [2] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [3] 0 0
Time to Total HF Hospitalizations (Including First and Recurrent Events)
Timepoint [3] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [4] 0 0
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
Timepoint [4] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [5] 0 0
Time to All-Cause Mortality
Timepoint [5] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [6] 0 0
Number of Participants Who Experienced One or More Adverse Events
Timepoint [6] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [7] 0 0
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Timepoint [7] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [8] 0 0
Percentage of Participants Who Experienced Symptomatic Hypotension
Timepoint [8] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary outcome [9] 0 0
Percentage of Participants Who Experienced Syncope
Timepoint [9] 0 0
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/09/2019
Sample size
Target
Accrual to date
Final
5050
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian VIGOUR Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Duke Clinical Research Institute
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mahesh J. Patel, MD
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://thecvc.ca/victoria/data-sharing/
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Pieske B, Patel MJ, Westerhout CM, Anstrom KJ, But... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02861534