clinical trial · NCT03013751
A Extension Study of Udenafil in Adolescents
Mezzion Pharma Co. Ltd·phase3·completed·n = 301
Functional Single Ventricle Heart DiseaseUdenafil
brief summary
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
started
Feb 6, 2017
primary completion
Dec 30, 2019
completion
Dec 20, 2022
last updated
Dec 9, 2025
detailed description
This will be an open-label extension study. All enrolled subjects will be provided with udenafil for the duration of the study. Subjects completing the Phase III FUEL study will be eligible for recruitment. Additional subjects will be recruited as needed to ensure a minimum of 300 total subjects enroll. Safety, pharmacodynamic and quality of life data will be collected and analyzed.
official title
A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol