Open-label Extension of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunctio

Phase 1

Recruiting

• Conditions: Heart Failure due to Systemic Left Ventricular Systolic Dysfunction; MedDRA version: 20.0Level: LLTClassification code: 10069501Term: Left ventricular systolic dysfunction Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10019279Term: Heart failure Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-506210-40-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Has received at least 1 dose of study intervention (vericiguat or placebo) and completed the Week 52 visit and safety follow-up period for the VALOR base study. This includes participants who prematurely discontinued study intervention unless premature discontinuation of study intervention was due to a drug related adverse event (AE) or to noncompliance with study intervention, Is able to receive medication via the oral or gastric route

Exclusion Criteria

Is hypotensive for age at Visit 1, Has undergone heart transplantation or has an implanted ventricular assist device, Has severe chronic kidney disease or requires chronic dialysis, Has hepatic disorder or Child Pugh Class C, Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study, Has concurrent or anticipated use of an soluble guanylate cyclase (sGC) stimulator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To monitor safety and tolerability of vericiguat (MK-1242).;Secondary Objective: To evaluate change in NT-proBNP from baseline to Week 16.;Primary end point(s): Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)