Fontan Udenafil Exercise Longitudinal Assessment Trial — FUEL  

Single Ventricle Heart Disease Clinical Trial

Official title: Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Heart Diseases
• Single Ventricle Heart Disease

• NCT number: NCT02741115
• Study type: Interventional
• Source: Mezzion Pharma Co. Ltd
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2016
• Completion date: April 30, 2019