Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
Phase of Trial: Phase III
Latest Information Update: 30 Jun 2017
At a glance
- Drugs Udenafil (Primary)
- Indications Congenital heart defects; Ventricular dysfunction
- Focus Registrational; Therapeutic Use
- Acronyms FUEL
- Sponsors Mezzion
- 25 Jul 2016 Status changed from not yet recruiting to recruiting.
- 20 Apr 2016 Status changed from planning to not yet recruiting.
- 23 Mar 2016 According to a Mezzion Pharma media release, the US FDA recently completed a special protocol assessment (SPA) review of two Phase III clinical protocols directed to the use of udenafil in adolescents with single ventricle congenital heart disease with Fontan physiology.