Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age29-17
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.

Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.

Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.

Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.

Trial design

Treatments tested in this trial

  • Vericiguat tablet
  • Vericiguat suspension
  • Placebo tablet
  • Placebo suspension

Treatment groups

342 Participants
are divided into 3 treatment groups

Sponsors and collaborators