Clinical Trial: A Extension Study of Udenafil in Adolescents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Mezzion Pharma Co. Ltd

Current Primary Outcome: Safety (Adverse Events) [ Time Frame: 52 Weeks ]

Adverse Events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Exercise (Change in maximal oxygen consumption) [ Time Frame: 52 Weeks ]
    Change in maximal oxygen consumption.
  • Echo (Change in myocardial performance Index) [ Time Frame: 52 Weeks ]
    Change in myocardial performance Index
  • Endothelial function (Change in log-transformed Reactive Hyperemia Index) [ Time Frame: 52 Weeks ]
    Change in log-transformed Reactive Hyperemia Index
  • Function Health Status (Change in full scale Peds QL) [ Time Frame: 52 Weeks ]
    Change in full scale Peds QL
  • Biomarkers (Change in serum BNP level) [ Time Frame: 52 Weeks ]
    Change in serum BNP level from baseline to end-of-study


Original Secondary Outcome: Same as current

Information By: Mezzion Pharma Co. Ltd

Dates:
Date Received: January 5, 2017
Date Started: January 2017
Date Completion: February 2019
Last Updated: April 20, 2017
Last Verified: January 2017