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 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.
As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
342
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo for vericiguat administered orally once daily in tablet form
Placebo for vericiguat administered orally once daily in suspension form
Loma Linda University Health System ( Site 0008)
Loma Linda, California, United States
RECRUITINGThe Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)
Los Angeles, California, United States
RECRUITINGChildren's Hospital Colorado ( Site 0012)
Aurora, Colorado, United States
RECRUITINGChildren's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Time frame: Baseline and Week 16 of Base Period
Extension Period: Percentage of participants with one or more adverse events (AEs)
An 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. The percentage of participants with one or more AEs in the Extension Period will be reported.
Time frame: Includes data collected up to a maximum of approximately 8 years
Extension Period: Percentage of participants who discontinued study drug due to an AE
An 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. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Time frame: Includes data collected up to a maximum of approximately 8 years
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP
The change from baseline to Week 52 of the Base Period in log-transformed NT-proBNP will be reported.
Time frame: Baseline and Week 52 of Base Period
Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
The time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization will be reported for the Base Period.
Time frame: Up to Week 54 of Base Period
Base Period: Percentage of participants with one or more adverse events (AEs)
An 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. The percentage of participants with one or more AEs in the Base Period will be reported.
Time frame: Up to Week 54 of Base Period
Base Period: Percentage of participants who discontinued study drug due to an AE
An 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. The percentage of participants who discontinue study drug in the Base Period due to an AE will be reported.
Time frame: Up to Week 52 of Base Period
Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Half-life (t1/2) of vericiguat in plasma
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the t1/2 of vericiguat in plasma.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Oral clearance (CL/F) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the CL/F of vericiguat in plasma.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP
The change from the Extension Period baseline to Week 16 of the Extension Period in log-transformed NT-proBNP will be reported.
Time frame: Extension Period Baseline (Study Week 54) and Extension Period Week 16 (Study Week 70)
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Johns Hopkins All Children's Hospital ( Site 0029)
St. Petersburg, Florida, United States
RECRUITINGChildren's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001)
Atlanta, Georgia, United States
RECRUITINGBoston Children's Hospital ( Site 0035)
Boston, Massachusetts, United States
RECRUITINGC.S. Mott Children's Hospital ( Site 0033)
Ann Arbor, Michigan, United States
RECRUITINGWashington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006)
St Louis, Missouri, United States
RECRUITINGColumbia University Medical Center-Pediatric Cardiology ( Site 0016)
New York, New York, United States
RECRUITING...and 87 more locations