A Extension Study of Udenafil in Adolescents
Public ClinicalTrials.gov record NCT03013751. 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
A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03013751
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 301 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
- Feb 6, 2017 (Actual)
- Primary completion
- Dec 30, 2019 (Actual)
- Completion
- Dec 20, 2022 (Actual)
- Last update posted
- Dec 9, 2025
2017 – 2022
United States locations
- U.S. sites
- 21
- U.S. states
- 19
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| 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 | — |
| Children's Hospital of New York | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| 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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03013751, 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 Dec 9, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03013751 live on ClinicalTrials.gov.