Fontan Udenafil Exercise Longitudinal Assessment Trial
Public ClinicalTrials.gov record NCT02741115. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02741115
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2016 (Actual)
- Primary completion
- Dec 27, 2018 (Actual)
- Completion
- Apr 30, 2019 (Actual)
- Last update posted
- Jun 17, 2025
2016 – 2019
United States locations
- U.S. sites
- 26
- U.S. states
- 22
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Cedars/Sinai Heart Institute | Los Angeles | California | 90048 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Cardiac Center/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20008 | — |
| Johns Hopkins All Children's Heart Institute | St. Petersburg | Florida | 33701 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Riley Hospital for Children/Herman B. Wells Center for Pediatric Research | Indianapolis | Indiana | 46201 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109-4204 | — |
| Children's Mercy Hospital Kansas City | Kansas City | Missouri | 64108 | — |
| Washington University St. Louis/St.Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| University of Nebraska Children's Hospital and Medical Center | Omaha | Nebraska | 68114 | — |
| Children's Hospital of New York | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hosptial | Columbus | Ohio | 43205 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Primary Children's Medical Hospital/Dept. of Pediatric Cardiology | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hosptial | Seattle | Washington | 98105 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02741115, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02741115 live on ClinicalTrials.gov.