NCT05714085 · Merck Sharp & Dohme LLC
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
What this study is about
This study aims to compare the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Vericiguat tablet
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
DRUG
Vericiguat suspension
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
DRUG
Placebo tablet
Placebo for vericiguat administered orally once daily in tablet form
DRUG
Placebo suspension
Placebo for vericiguat administered orally once daily in suspension form
Primary outcome measures
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: Baseline and Week 16 of Base Period
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Extension Period: Percentage of participants with one or more adverse events (AEs)
Time frame: Includes data collected up to a maximum of approximately 8 years
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.
Extension Period: Percentage of participants who discontinued study drug due to an AE
Time frame: Includes data collected up to a maximum of approximately 8 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.
- Has biventricular physiology with a morphologic systemic left ventricle.
- Is currently receiving stable medical therapy for HF.
- Has left ventricular ejection fraction (LVEF) \<45% assessed within 3 months before randomization.
- Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate.
- Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.
- Extension Period: Was randomized, receive
Where
- Los Angeles, California
- Palo Alto, California
- San Bernardino, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- St. Petersburg, Florida
- Atlanta, Georgia
- Boston, Massachusetts
- Ann Arbor, Michigan
- St Louis, Missouri
- New York, New York
- The Bronx, New York
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations