Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
NCT ID: NCT05918211
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
436 participants
INTERVENTIONAL
2023-10-30
2025-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug
Approximately 218 subjects dosed with udenafil will be enrolled at approximately 30 sites.
Udenafil
Active drug
Placebo
Approximately 218 subjects dosed with matching placebo will be enrolled at approximately 30 sites.
Placebo
Matching Placebo
Interventions
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Udenafil
Active drug
Placebo
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
2. Participant consent or parental/guardian consent and participant assent.
3. Participant fluency in primary language of country in which study is being conducted.
4. Current antiplatelet or anticoagulant therapy.
Exclusion Criteria
2. Weight \< 40 kg.
3. Hospitalization for acute decompensated heart failure within the last 12 months.
4. Current intravenous inotropic drugs.
5. Undergoing evaluation for heart transplantation or listed for transplantation.
6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
7. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \> 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
8. Single lung physiology with greater than 80% flow to one lung.
9. Failure to achieve maximal exertion (defined as RER \< 1.10) on screening/baseline exercise test.
10. Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.
11. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.
12. Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
13. History of significant renal (serum creatinine \> 2.0), hepatic (serum AST and/or ALT \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications.
14. Inability to complete exercise testing at baseline screening.
15. Subjects with a pacemaker whose heart rate at peak exercise is controlled by the extrinsic pacemaker as opposed to a native atrial rhythm.
16. History of PDE-5 inhibitor use within 12 months prior to enrollment. (Treatment is defined as chronic therapy as opposed to a single dose.)
17. History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
18. Known intolerance to oral udenafil.
19. Frequent use of medications or other substances that inhibit or induce CYP3A4.
20. Current use of alpha-blockers or nitrates.
21. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
22. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
23. Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
24. For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration if sexually active.
25. Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial.
26. Refusal to provide written informed consent/assent.
27. In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.
28. History of clinically significant thromboembolic event, in the option of the site Principal Investigator, that may put the subject at increased risk of a subsequent event while participating in the study.
29. Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.
30. Not taking antiplatelet or anticoagulant therapy.
12 Years
18 Years
ALL
No
Sponsors
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Mezzion Pharma Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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WG Kim
Role: STUDY_DIRECTOR
Mezzion Pharma Co. Ltd
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Nemours Children's Hospital
Wilmington, Delaware, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Hospital of Georgia
Augusta, Georgia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Children's Hospital and Medical Center
Omaha, Nebraska, United States
Mt. Sinai Children's Hospital
New York, New York, United States
New York-Presbyterian Children's Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
MUSC Pediatric Research Group
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Sejong General Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Children's Hospital
Seoul, , South Korea
Yonsei Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MZ_Udenafil-05
Identifier Type: -
Identifier Source: org_study_id
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