CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
Udenafildrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03013751
NCT03013751Phase 3Completed
CompareCT.gov

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

Mezzion Pharma Co. Ltd·interventional·Posted Jan 6, 2017·Updated Dec 9, 2025

In Brief

A Phase 3 clinical trial evaluating Udenafil for Functional Single Ventricle Heart Disease. Completed, enrolled 301 participants across 24 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Single Ventricle Heart Disease
CountriesCanada, South Korea, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 6, 2017
Enrollment StartFeb 6, 2017
Primary CompletionDec 30, 2019
Study CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.5 years ago

Interventions

Udenafildrug

Active drug