Fuel OLE Study of Udenafil After Fontan Treatment - Clinical Trial
What is the Purpose of this Study?
Who Can Participate in the Study?
- Are between the ages of 12 and 19 years old.
- Have Fontan physiology.
- Weigh more than 40kg (about 88 pounds).
- Are taller than 132cm (about 52 inches).
What is Involved?
If you would like for your child to be part of this study, your child will:
- Be involved in the study for about 15 months.
- Be given the study medicine, Udenafil.
- Have 2 in-person visits.
- Have 16 brief phone calls over 15 months.
- Be asked to do the following tests: Physical Exam, blood test, echocardiogram, exercise test, resting lung test, and electrocardiogram.