Open-label Extension of MK-1242 in Pediatric Ppts with HF due to LVSD
Research type
Research Study
Full title
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)
IRAS ID
1008485
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Heart Failure (HF) is a serious disease in which the heart does not pump enough blood to the body. Vericiguat is a novel oral sGC (soluble guanylate cyclase) stimulator indicated to reduce the risk of cardiovascular death and heart failure hospitalisation. The purpose of this study is to provide vericiguat to children with HF. This is an extension study, which means children who took part in and completed the first study of vericiguat can join. Approximately 342 participants will have the opportunity to complete the VALOR base study and be evaluated for enrolment in this extension study.
The main objective of the trial is:
• To monitor safety and tolerability of vericiguat in participants who have completed the VALOR base study.
• To evaluate change in NT-proBNP from baseline to Week 16
Vericiguat will be administered orally as liquid suspension or tablet. The maintenance dose of vericiguat will be achieved using a titration procedure based on the children’s blood pressure and symptoms. Children with weight ≥40 kg will receive adult dosing regimen using tablets, or oral suspension with a starting dose of 2.5mg once a day (Dose Level 1) with a dose doubling every 2 weeks as tolerated to the targeted 10 mg dose (Dose Level 3). Children <40 kg will receive paediatric dose equivalents of the oral suspension and follow a similar titration from Dose Level 1 to Level 3.
Children will be evaluated in the clinic at Weeks 6 & 16, then every 16 weeks until Week 48. Telephone contacts will be performed at Weeks 10, 24, & 40. Following Week 48 visit, children will be evaluated in clinic every 24 weeks thereafter.
Children may be able to stay in the study until vericiguat becomes available to them through their regular medical care or an access program. They may be in this study for as long as about 8 years, depending on when they completed the previous study.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0001
Date of REC Opinion
9 May 2024
REC opinion
Further Information Favourable Opinion