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

Phase 2/3 Recruiting 342 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2023-05-31
Primary completion: 2032-04-15
Completion: 2032-04-15

Publications

Fritsch A, Meyer M, Blaustein RO, Trujillo ME, Kauh E, Roessig L, Boettcher M, Becker C. Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat. Clin Pharmacokinet. 2024 Jun;63(6):751-771. doi: 10.1007/s40262-024-01384-1. Epub 2024 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vericiguat	Other / unclassified	0.2 mg/ml	Oral
Subject	Vericiguat	Other / unclassified	1 mg/ml	Oral
Subject	Vericiguat	Other / unclassified	2.5 mg	Oral
Subject	Vericiguat	Other / unclassified	5 mg	Oral
Subject	Vericiguat	Other / unclassified	10 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications