Open-label Extension of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction
Key facts
- Where
- Budapest, MagyarországSee the site
- Phase
- 3. fázis
Where in Magyarország
- Gottsegen National Cardiovascular CenterBudapest, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2023-506210-40-00
- Record updated
- 2025. április 23.
- Original description
To monitor safety and tolerability of vericiguat (MK-1242).Read full original descriptionShow less
A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)
To monitor safety and tolerability of vericiguat (MK-1242).
Inclusion: 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: 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; 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; Is hypotensive for age at Visit 1.