clinical trial · NCT05918211
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Mezzion Pharma Co. Ltd·phase3·recruiting·n = 436
Single Ventricle Heart DiseaseUdenafilPlacebo
brief summary
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
started
Oct 30, 2023
primary completion
Oct 28, 2025
completion
Oct 28, 2025
last updated
Oct 28, 2025
detailed description
This study is a 26 week, prospective, multicenter, randomized, double-blinded, placebo-controlled safety and efficacy study of udenafil vs. placebo in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption (VO2 mL/kg/min) as measured by maximal cardiopulmonary exercise test (CPET) reading laboratory who will be blinded to treatment allocation.
official title
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol