Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

Trial Profile

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

Recruiting
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
  • Most Recent Events

    • 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.
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