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A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035) (VICTOR)

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ClinicalTrials.gov Identifier: NCT05093933
Recruitment Status : Recruiting
First Posted : October 26, 2021
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE October 18, 2021
First Posted Date  ICMJE October 26, 2021
Last Update Posted Date January 26, 2023
Actual Study Start Date  ICMJE November 2, 2021
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization [ Time Frame: From date of randomization until the date of first occurrence of a CV death or HF hospitalization, assessed up to approximately 40 months ]
The first event of CV death or HF hospitalization as confirmed by a clinical events committee (CEC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
  • Time to First Occurrence of CV Death [ Time Frame: From date of randomization until the date of first occurrence of a CV death, assessed up to approximately 40 months ]
    The first event of CV death as confirmed by a CEC.
  • Time to First Occurrence of HF Hospitalization [ Time Frame: From date of randomization until the date of first occurrence of a HF hospitalization, assessed up to approximately 40 months ]
    The first event of HF hospitalization as confirmed by a CEC.
  • Time to Total HF Hospitalizations (Including First and Recurrent Events) [ Time Frame: Up to approximately 40 months ]
    All events of HF hospitalization as confirmed by a CEC.
  • Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization [ Time Frame: From date of randomization until the date of first occurrence of death or HF hospitalization, assessed up to approximately 40 months ]
    The first event of death due to any cause or HF hospitalization as confirmed by a CEC.
  • Time to All-Cause Mortality [ Time Frame: From date of randomization until the date of death, assessed up to approximately 40 months ]
    The first event of death due to any cause as confirmed by a CEC.
  • Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAEs) [ Time Frame: Up to approximately 40 months ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Selected NSAEs are nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or coronavirus disease (COVID-19) disease-related AEs.
  • Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 40 months ]
    An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, as judged medically or scientifically, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.
  • Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs) [ Time Frame: Up to approximately 40 months ]
    Events of clinical interest will include: 1) Potential drug-induced liver injury (DILI) events defined as: elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, as determined by way of protocol specified laboratory testing or unscheduled laboratory testing, 2) Symptomatic hypotension 3) Anemia.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure With Reduced Ejection Fraction
Intervention  ICMJE
  • Drug: Vericiguat
    2.5, 5.0, or 10.0 mg orally once daily
    Other Names:
    • MK-1242
    • BAY 1021189
  • Drug: Placebo
    0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vericiguat
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2021)
6000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Peru,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05093933
Other Study ID Numbers  ICMJE 1242-035
MK-1242-035 ( Other Identifier: Merck )
2022-500881-80-00 ( Registry Identifier: EU CT )
2020-005941-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP