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Open-label Extension of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction
EU CTIS ID: 2023-506210-40-00
What this study is testing
To monitor safety and tolerability of vericiguat (MK-1242).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Peru
- New Zealand
- Turkey
- Colombia
- United Kingdom
- Singapore
- Thailand
- Canada
- Brazil
- South Africa
- Malaysia
- United States
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Peru; New Zealand; Turkey; Colombia; United Kingdom and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.