NCT05918211

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (estimated)
• 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 who have had the Fontan procedure.

Detailed description

This study is a 26 week, prospective, multicenter, randomized, double-blinded, placebo-controlled safety and efficacy study of udenafil vs. placebo in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption (VO2 mL/kg/min) as measured by maximal cardiopulmonary exercise test (CPET) reading laboratory who will be blinded to treatment allocation.

Conditions

• Single Ventricle Heart Disease

Interventions

Type	Name	Description
DRUG	Udenafil	Active drug
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2023-06-26
• Last updated: 2025-10-28

Locations

40 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study