Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
Status: Completed
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:
• Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.
• Participant consent or parental/guardian consent and participant assent
• Participant fluency in primary language of country in which study is being conducted
Locations
United States
Arizona
Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital
Phoenix
California
Cedars/Sinai Heart Institute
Los Angeles
Children's Hospital Los Angeles
Los Angeles
Rady Children's Hospital
San Diego
Colorado
Children's Hospital Colorado
Aurora
Washington, D.c.
Children's National Medical Center
Washington
Delaware
Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington
Florida
Johns Hopkins All Children's Heart Institute
Saint Petersburg
Georgia
Children's Healthcare of Atlanta
Atlanta
Indiana
Riley Hospital for Children/Herman B. Wells Center for Pediatric Research
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital
Ann Arbor
Missouri
Children's Mercy Hospital Kansas City
Kansas City
Washington University St. Louis/St.Louis Children's Hospital
Saint Louis
North Carolina
Duke University Medical Center
Durham
Nebraska
University of Nebraska Children's Hospital and Medical Center
Omaha
New York
Children's Hospital of New York
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Nationwide Children's Hosptial
Columbus
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Texas Children's Hospital
Houston
Utah
Primary Children's Medical Hospital/Dept. of Pediatric Cardiology
Salt Lake City
Washington
Seattle Children's Hosptial
Seattle
Wisconsin
Children's Hospital of Wisconsin
Milwaukee
Other Locations
Canada
Stollery Children's Hospital - University of Alberta
Edmonton
The Hospital for Sick Children
Toronto
Republic of Korea
Sejong General Hospital
Bucheon-si
Seoul National University Children's Hospital
Seoul
Time Frame
Start Date: 2016-07-22
Completion Date: 2019-04-30
Participants
Target number of participants: 400
Treatments
Experimental: Drug
Udenafil. One tablet twice daily for 26 weeks
Experimental: Placebo
Placebo. One tablet twice daily for 26 weeks
Authors
Anitha John, Kurt R Schumacher, Naomi Kertesz, Matthew Files, Ruchira Garg, Charles Canter, Jonathan B Wagner, Benjamin Frischhertz, Marc Richmond, Bryan H Goldstein, Christopher Davis, Ryan Butts, Tabitha G Moe, Daniel Penny, Christopher Petit, Shaji C Menon, Amanda Shillingford, Stephen Paridon, Girish Shirali, Angela Yetman, Arash Sabati, Seema Mital, Brian McCrindle, Andrew S Mackie, Gi Beom Kim
Sponsors
Leads: Mezzion Pharma Co. Ltd
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)