Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)
- Conditions
- Systolic Dysfunction
- Interventions
- Registration Number
- NCT06428383
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The primary objective of this study is to monitor the safety and tolerability of vericiguat.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 342
- Was randomized, 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.
- A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
- Is able to receive medication via the oral or gastric route .
- Is hypotensive for age at Visit 1
- Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
- Has undergone heart transplantation or has an implanted ventricular assist device.
- Has severe chronic kidney disease
- Has hepatic disorder
- Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
- Has concurrent or anticipated use of an sGC stimulator.
- Is both ≥18 years of age and vericiguat is commercially available to the participant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vericiguat Vericiguat tablet Vericiguat administered orally in either tablet or suspension once daily until end of treatment Vericiguat Vericiguat suspension Vericiguat administered orally in either tablet or suspension once daily until end of treatment
- Primary Outcome Measures
Name Time Method Participants who discontinued study drug due to an AE Up to approximately 8 years Percentage of participants who discontinued study drug due to an AE
Participants with adverse events (AEs) Up to approximately 8 years Percentage of participants with AEs
- Secondary Outcome Measures
Name Time Method Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP) Baseline and Week 16 Change in NT-proBNP from baseline at Week 16.
Trial Locations
- Locations (7)
Le Bonheur Children's Hospital ( Site 0007)
🇺🇸Memphis, Tennessee, United States
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)
🇨🇴Rionegro, Antioquia, Colombia
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
🇮🇪Dublin, Ireland
Fundacion Valle del Lili- CIC ( Site 0604)
🇨🇴Cali, Valle Del Cauca, Colombia
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
🇭🇺Budapest, Hungary
Faculty of Medicine Siriraj Hospital ( Site 3200)
🇹🇭Thailand, Krung Thep Maha Nakhon, Thailand
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
🇹🇭Chiang Mai, Thailand