Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents (NCT02201342) | Clinical Trial Compass
CompletedPhase 1/2
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
United States, Canada36 participantsStarted 2014-07
Plain-language summary
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.
Who can participate
Age range
14 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females with Fontan physiology who are 14-18 years of age.
. Willingness to return to center to complete blood draws and exercise tests as described in the study protocol.
. Patients must agree to abstain from alcohol, caffeinated beverages, and grapefruit juice for the duration of the trial.
. Informed assent from subject informed consent from parent/legal guardian as appropriate.
Exclusion criteria
. Non-cardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
. Height \<132 cm (minimum height requirement for exercise stress testing).
. 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.
. Single lung physiology.
. Severe ventricular dysfunction or valvular regurgitation (systemic atrioventricular or semilunar valve) determined from review of the echocardiogram performed in closest proximity to study enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects With Serious Adverse Events Possibly or Probably Related to Udenafil
. Significant renal (serum creatinine \> 2.0), hepatic (serum aspartate aminotransferase (AST) and/or alanine aminotransferase ( ALT) \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications, based on laboratory assessment at the time of screening visit.
. Hospitalization for acute decompensated heart failure within the 12 months preceding study enrollment.
. A diagnosis of active protein losing enteropathy or plastic bronchitis.