A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation
Phase of Trial: Phase III
Latest Information Update: 16 Mar 2018
At a glance
- Drugs Udenafil (Primary)
- Indications Congenital heart defects; Ventricular dysfunction
- Focus Adverse reactions
- Sponsors Mezzion
- 20 Apr 2017 Status changed from not yet recruiting to recruiting.
- 29 Mar 2016 New trial record
- 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. Udenafil was granted Orphan Drug designation by the FDA in 2015.