NCT02741115

Fontan Udenafil Exercise Longitudinal Assessment Trial

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Mezzion Pharma Co. Ltd · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs. placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six months in adolescent survivors of the Fontan procedure. . The target sample size is 400 subjects (200 per group).

Conditions

• Single Ventricle Heart Disease

Interventions

Type	Name	Description
DRUG	Udenafil	Active drug
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2016-07-22
• Primary completion: 2018-12-27
• Completion: 2019-04-30
• First posted: 2016-04-18
• Last updated: 2025-06-17
• Results posted: 2025-05-21

Locations

30 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study