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

Conditions

• Heart Failure
• Left Ventricular Systolic Dysfunction

Eligibility Criteria

Sex

ALL

Age

29 Days - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Vericiguat tablet — DRUG
  2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
• Vericiguat suspension — DRUG
  0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
• Placebo tablet — DRUG
  Placebo for vericiguat administered orally once daily in tablet form
• Placebo suspension — DRUG
  Placebo for vericiguat administered orally once daily in suspension form

Study Details

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.

Key Dates

Start date

May 31, 2023

Status verified

May 2026

Primary completion

Apr 15, 2032

Completion

Apr 15, 2032

Study Design

Enrollment

342 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Base Period: Vericiguat
  Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks.
• Placebo Comparator: Base Period: Placebo
  Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.
• Experimental: Extension Period: Vericiguat
  Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.

Primary Outcome Measure

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 ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (20)

Find similar trials in Los Angeles, CA

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