Trial Profile

A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 07 Nov 2022

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At a glance

Drugs Udenafil (Primary)
Indications Congenital heart defects; Ventricular dysfunction
Focus Adverse reactions
Acronyms FUELExten
Sponsors Mezzion

Most Recent Events

21 Dec 2021 According to a Mezzion media release, new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) was presented to the U.S. Food and Drug Administration (FDA) in a Type C meeting held on December 16, 2021.
22 Nov 2020 Planned End Date changed from 1 Jul 2020 to 1 Dec 2020.
08 Jan 2020 Planned End Date changed from 1 Dec 2019 to 1 Jul 2020.

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