Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Mezzion Pharma Co. Ltd
- Study ID
- NCT05918211
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Single Ventricle Heart Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Udenafil — DRUGActive drug
- Placebo — DRUGMatching Placebo
Study Details
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 who have had the Fontan procedure.
Key Dates
- Start date
- Oct 30, 2023
- Status verified
- Oct 2025
- Primary completion
- Oct 28, 2025
- Completion
- Oct 28, 2025
Study Design
- Enrollment
- 436 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DrugApproximately 218 subjects dosed with udenafil will be enrolled at approximately 30 sites.
- Experimental: PlaceboApproximately 218 subjects dosed with matching placebo will be enrolled at approximately 30 sites.
Primary Outcome Measure
Change in Exercise Capacity [ Time Frame: Baseline to 26 Weeks ]
Central Contacts
- WG Kim443.699.6746
Locations (37)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | Arash Sabati, MD (PRINCIPAL_INVESTIGATOR) |
| Arkansas Children's | Little Rock | Arkansas | 72202 | Wendy Haley haleyw@archildren's.org 501-364-2237 Dala Zakaria, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | Jon Detterich, MD (PRINCIPAL_INVESTIGATOR) |
| Rady Children's Hospital | San Diego | California | 92123 | Jessica Haley, MD (PRINCIPAL_INVESTIGATOR) |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | Doaa Aly, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Colorado | Denver | Colorado | 80045 | Roni Jacobsen (PRINCIPAL_INVESTIGATOR) |
| Yale School of Medicine | New Haven | Connecticut | 06510 | Meredith Leslie, MD (PRINCIPAL_INVESTIGATOR) |
| Nemours Children's Hospital | Wilmington | Delaware | 19803 | Mark Cartoski, MD (PRINCIPAL_INVESTIGATOR) |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | Sairah Khan, MD (PRINCIPAL_INVESTIGATOR) |
| UF Health Shands Hospital | Gainesville | Florida | 32608 | Dipankar Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | Melissa Diamond, MD (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | Jamie Decker, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | Michael Lopez, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Georgia | Augusta | Georgia | 30912 | Mark Vranicar, MD (PRINCIPAL_INVESTIGATOR) |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | Kendra Ward, MD (PRINCIPAL_INVESTIGATOR) |
| University of Chicago | Chicago | Illinois | 60637 | Michael Earing, MD (PRINCIPAL_INVESTIGATOR) |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Rahul Rathod, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Kurt Schumacher, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Mercy Hospital Kansas City | Kansas City | Missouri | 64108 | Jonathan B Wagner, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63130 | William Orr, MD (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska Children's Hospital and Medical Center | Omaha | Nebraska | 68114 | Angela Yetman, MD (PRINCIPAL_INVESTIGATOR) |
| Mt. Sinai Children's Hospital | New York | New York | 10029 | Neha Bansel, MD (PRINCIPAL_INVESTIGATOR) |
| New York-Presbyterian Children's Hospital | New York | New York | 10032 | Christopher Petit, MD (PRINCIPAL_INVESTIGATOR) |
| [email protected] | Charlotte | North Carolina | 28204 | Matthew Schwartz, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | Alexi Pifer Melissa Harward Gregory Fleming, MD (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45206 | Sasha Opotowsky, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Shahnawaz Amdani, MD (PRINCIPAL_INVESTIGATOR) |
| Nationwide Children's Hospital | Columbus | Ohio | 43215 | Omar Khalid, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Jon Edelson, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Lauren Carlozzi, MD (PRINCIPAL_INVESTIGATOR) |
| MUSC Pediatric Research Group | Charleston | South Carolina | 29425 | Andrew Atz, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Benjamin Frischhertz, MD (PRINCIPAL_INVESTIGATOR) |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | Matt Lemler, MD (PRINCIPAL_INVESTIGATOR) |
| Texas Children's Hospital | Houston | Texas | 77030 | Daniel Penny, MD (PRINCIPAL_INVESTIGATOR) |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | Richard Williams, MD (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Matthew Files, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | Stephanie Handler, MD (PRINCIPAL_INVESTIGATOR) |
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