At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
Udenafil +1 moredrug
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.
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
In Brief
A Phase 3 clinical trial evaluating Udenafil and Placebo for Single Ventricle Heart Disease. Completed, enrolled 400 participants across 30 sites in 3 countries.
Detailed Summary
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSingle Ventricle Heart Disease
CountriesCanada, South Korea, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionDec 2018
Study CompletionApr 2019
TodayJul 2026
First PostedApr 18, 2016
Enrollment StartJul 22, 2016
Primary CompletionDec 27, 2018
Study CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.2 years ago
Interventions
Udenafildrug
Active drug
Placebodrug
Matching Placebo