A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

Summary

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.

Description

Eligibility

Age range

0–17 years

Sex

All

Healthy volunteers

No

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

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