NCT03013751

A Extension Study of Udenafil in Adolescents

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Mezzion Pharma Co. Ltd · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be an open-label extension study. All enrolled subjects will be provided with udenafil for the duration of the study. Subjects completing the Phase III FUEL study will be eligible for recruitment. Additional subjects will be recruited as needed to ensure a minimum of 300 total subjects enroll. Safety, pharmacodynamic and quality of life data will be collected and analyzed.

Conditions

• Functional Single Ventricle Heart Disease

Interventions

Type	Name	Description
DRUG	Udenafil	Active drug

Timeline

• Start date: 2017-02-06
• Primary completion: 2019-12-30
• Completion: 2022-12-20
• First posted: 2017-01-06
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

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

Regulatory

• FDA-regulated drug study