clinical trial · NCT02741115
Fontan Udenafil Exercise Longitudinal Assessment Trial
Mezzion Pharma Co. Ltd·phase3·completed·n = 400
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 subjects who have undergone the Fontan procedure.
started
Jul 22, 2016
primary completion
Dec 27, 2018
completion
Apr 30, 2019
last updated
Jun 17, 2025
detailed description
This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs. placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six months in adolescent survivors of the Fontan procedure. . The target sample size is 400 subjects (200 per group).
official title
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol