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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05093933




Registration number
NCT05093933
Ethics application status
Date submitted
18/10/2021
Date registered
26/10/2021

Titles & IDs
Public title
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
Scientific title
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
Secondary ID [1] 0 0
MK-1242-035
Secondary ID [2] 0 0
1242-035
Universal Trial Number (UTN)
Trial acronym
VICTOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Experimental: Vericiguat - Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily. The vericiguat dose will be titrated to 5 mg and to 10 mg.

Placebo comparator: Placebo - Participants receive a starting matching placebo to vericiguat dose of 2.5 mg taken orally once daily. The matching placebo dose will be sham titrated to 5 mg and to 10 mg.


Treatment: Drugs: Vericiguat
2.5, 5.0, or 10.0 mg orally once daily

Treatment: Drugs: Placebo
0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat
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
From date of randomization until the date of first occurrence of a CV death or HF hospitalization, assessed up to approximately 40 months
Secondary outcome [1] 0 0
Time to First Occurrence of CV Death
Timepoint [1] 0 0
From date of randomization until the date of first occurrence of a CV death, assessed up to approximately 40 months
Secondary outcome [2] 0 0
Time to First Occurrence of HF Hospitalization
Timepoint [2] 0 0
From date of randomization until the date of first occurrence of a HF hospitalization, assessed up to approximately 40 months
Secondary outcome [3] 0 0
Time to Total HF Hospitalizations (Including First and Recurrent Events)
Timepoint [3] 0 0
Up to approximately 40 months
Secondary outcome [4] 0 0
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
Timepoint [4] 0 0
From date of randomization until the date of first occurrence of death or HF hospitalization, assessed up to approximately 40 months
Secondary outcome [5] 0 0
Time to All-Cause Mortality
Timepoint [5] 0 0
From date of randomization until the date of death, assessed up to approximately 40 months
Secondary outcome [6] 0 0
Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAEs)
Timepoint [6] 0 0
Up to approximately 40 months
Secondary outcome [7] 0 0
Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to approximately 40 months
Secondary outcome [8] 0 0
Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)
Timepoint [8] 0 0
Up to approximately 40 months

Eligibility
Key inclusion criteria
* History of chronic HF [New York Heart Association (NYHA) Class II to IV] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
* Left ventricular ejection fraction (LVEF) of =40%, assessed within 12 months before randomization by any imaging method.
* Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has SBP <100 mm Hg or symptomatic hypotension.
* Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
* Amyloidosis or sarcoidosis.
* Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
* Hypertrophic cardiomyopathy.
* Acute myocarditis or Takotsubo cardiomyopathy.
* History of heart transplant.
* Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
* Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
* History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
* Malignancy or other noncardiac condition limiting life expectancy to <3 years.
* Requires continuous home oxygen for severe pulmonary disease.
* Interstitial lung disease.
* Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
* Recent history (within the last year) of drug or alcohol abuse or dependence.

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 administering the treatment/s
The people assessing the outcomes
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
Accrual to date
Final
6105
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital-Cardiology Research ( Site 0453) - Brisbane
Recruitment hospital [2] 0 0
The Prince Charles Hospital-Cardiology Research Centre ( Site 0451) - Brisbane
Recruitment hospital [3] 0 0
Core Research Group ( Site 0452) - Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital-Cardiology ( Site 0456) - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre-Cardiology Research ( Site 0455) - Bedford Park
Recruitment hospital [6] 0 0
St. John of God Subiaco Hospital ( Site 0457) - Subiaco
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4064 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
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Podkarpackie
Country [208] 0 0
Poland
State/province [208] 0 0
Podlaskie
Country [209] 0 0
Poland
State/province [209] 0 0
Pomorskie
Country [210] 0 0
Puerto Rico
State/province [210] 0 0
Bayamon
Country [211] 0 0
Puerto Rico
State/province [211] 0 0
Humacao
Country [212] 0 0
Puerto Rico
State/province [212] 0 0
Ponce
Country [213] 0 0
Puerto Rico
State/province [213] 0 0
Rio Grande
Country [214] 0 0
Puerto Rico
State/province [214] 0 0
San Juan
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Ivanovskaya Oblast
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Krasnodarskiy Kray
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Leningradskaya Oblast
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Moskva
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Omskaya Oblast
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Permskiy Kray
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Rostovskaya Oblast
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Ryazanskaya Oblast
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Sankt-Peterburg
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Saratovskaya Oblast
Country [225] 0 0
Russian Federation
State/province [225] 0 0
Tatarstan, Respublika
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Volgogradskaya Oblast
Country [227] 0 0
Singapore
State/province [227] 0 0
Central Singapore
Country [228] 0 0
Singapore
State/province [228] 0 0
South East
Country [229] 0 0
Singapore
State/province [229] 0 0
South West
Country [230] 0 0
South Africa
State/province [230] 0 0
Free State
Country [231] 0 0
South Africa
State/province [231] 0 0
Gauteng
Country [232] 0 0
South Africa
State/province [232] 0 0
Kwazulu-Natal
Country [233] 0 0
South Africa
State/province [233] 0 0
Western Cape
Country [234] 0 0
Spain
State/province [234] 0 0
Barcelona
Country [235] 0 0
Spain
State/province [235] 0 0
Cataluna
Country [236] 0 0
Spain
State/province [236] 0 0
La Coruna
Country [237] 0 0
Spain
State/province [237] 0 0
Madrid, Comunidad De
Country [238] 0 0
Spain
State/province [238] 0 0
Valenciana, Comunitat
Country [239] 0 0
Spain
State/province [239] 0 0
Madrid
Country [240] 0 0
Spain
State/province [240] 0 0
Sevilla
Country [241] 0 0
Sweden
State/province [241] 0 0
Dalarnas Lan
Country [242] 0 0
Sweden
State/province [242] 0 0
Orebro Lan
Country [243] 0 0
Sweden
State/province [243] 0 0
Skane Lan
Country [244] 0 0
Sweden
State/province [244] 0 0
Stockholms Lan
Country [245] 0 0
Sweden
State/province [245] 0 0
Vasterbottens Lan
Country [246] 0 0
Sweden
State/province [246] 0 0
Vastmanlands Lan
Country [247] 0 0
Sweden
State/province [247] 0 0
Vastra Gotalands Lan
Country [248] 0 0
Taiwan
State/province [248] 0 0
Changhua
Country [249] 0 0
Taiwan
State/province [249] 0 0
Hsinchu
Country [250] 0 0
Taiwan
State/province [250] 0 0
Kaohsiung
Country [251] 0 0
Taiwan
State/province [251] 0 0
Taichung
Country [252] 0 0
Taiwan
State/province [252] 0 0
Taipei
Country [253] 0 0
Taiwan
State/province [253] 0 0
Taoyuan
Country [254] 0 0
Turkey
State/province [254] 0 0
Izmir
Country [255] 0 0
Turkey
State/province [255] 0 0
Afyonkarahisar
Country [256] 0 0
Turkey
State/province [256] 0 0
Ankara
Country [257] 0 0
Turkey
State/province [257] 0 0
Antalya
Country [258] 0 0
Turkey
State/province [258] 0 0
Eskisehir
Country [259] 0 0
Turkey
State/province [259] 0 0
Istanbul
Country [260] 0 0
Turkey
State/province [260] 0 0
Kocaeli
Country [261] 0 0
Turkey
State/province [261] 0 0
Mersin
Country [262] 0 0
Ukraine
State/province [262] 0 0
Cherkaska Oblast
Country [263] 0 0
Ukraine
State/province [263] 0 0
Ivano-Frankivska Oblast
Country [264] 0 0
Ukraine
State/province [264] 0 0
Kharkivska Oblast
Country [265] 0 0
Ukraine
State/province [265] 0 0
Khmelnytska Oblast
Country [266] 0 0
Ukraine
State/province [266] 0 0
Kyivska Oblast
Country [267] 0 0
Ukraine
State/province [267] 0 0
Kyiv
Country [268] 0 0
Ukraine
State/province [268] 0 0
Odeska Oblast
Country [269] 0 0
Ukraine
State/province [269] 0 0
Vinnytska Oblast
Country [270] 0 0
Ukraine
State/province [270] 0 0
Volynska Oblast
Country [271] 0 0
Ukraine
State/province [271] 0 0
Zakarpatska Oblast
Country [272] 0 0
Ukraine
State/province [272] 0 0
Zaporizka Oblast
Country [273] 0 0
Ukraine
State/province [273] 0 0
Zhytomyrska Oblast
Country [274] 0 0
United Kingdom
State/province [274] 0 0
Cumbria
Country [275] 0 0
United Kingdom
State/province [275] 0 0
Derbyshire
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Dundee City
Country [277] 0 0
United Kingdom
State/province [277] 0 0
England
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Great Britain
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Lancashire
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Lisburn And Castlereagh
Country [281] 0 0
United Kingdom
State/province [281] 0 0
London, City Of
Country [282] 0 0
United Kingdom
State/province [282] 0 0
Northern Ireland
Country [283] 0 0
United Kingdom
State/province [283] 0 0
Wales
Country [284] 0 0
United Kingdom
State/province [284] 0 0
Walsall
Country [285] 0 0
United Kingdom
State/province [285] 0 0
Worcestershire
Country [286] 0 0
United Kingdom
State/province [286] 0 0
Blackpool
Country [287] 0 0
United Kingdom
State/province [287] 0 0
Coventry
Country [288] 0 0
United Kingdom
State/province [288] 0 0
Poole
Country [289] 0 0
United Kingdom
State/province [289] 0 0
Stockton-On-Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
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?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bona... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT05093933