2023-506210-40-00CompletedPhase 3
Open-label Extension of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Apr 2025
Brief summary (registry, in English)
To monitor safety and tolerability of vericiguat (MK-1242).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 16 Nov 2023
- Start date
- 28 Jun 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Heart failure
- EU CT number
- 2023-506210-40-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 99
- 29 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Is hypotensive for age at Visit 1
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent | Gent | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| Centre Hospitalier Regional de la Citadelle | Liège | Belgium | Completed |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Completed |
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Completed |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Completed |
| Medizinische Hochschule Hannover | Hanover | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Completed |
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| Sant Joan De Deu Barcelona Hospital | Esplugues De Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| Tampere University Hospital | Tampere | Finland | Completed |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Completed |
| Assistance Publique Hôpitaux de Marseille | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Completed |
| Hopital Necker Enfants Malades | Paris | France | Completed |
| Robert Debre University Hospital | Paris | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Completed |
| Gottsegen National Cardiovascular Center | Budapest | Hungary | Completed |
| Children's Health Ireland | Dublin | Ireland | Completed |
| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence | Italy | Completed |
| Azienda Ospedale Universita Padova | Padova | Italy | Completed |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Centro Hospitalar De Lisboa Ocidental E.P.E. | Carnaxide | Portugal | Completed |
| Centro Hospitalar Universitario De Lisboa Norte E.P.E. | Lisbon | Portugal | Completed |
| Sao Joao University Hospital Center | Porto | Portugal | Completed |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.