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Home Clinical Trials at Duke Clinical Trials Directory

Fuel OLE Study of Udenafil After Fontan Treatment - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to learn whether children who have had the Fontan operation can improve their ability to exercise by taking the study medicine called Udenafil.
What is the Condition Being Studied?
Single Ventricle Physiology after Fontan Palliation

Who Can Participate in the Study?

Children who:
- 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). 

Age Group
Adults, Children

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.

Study Details

Full Title
A PHASE III SAFETY EXTENSION STUDY OF UDENAFIL IN ADOLESCENTS WITH SINGLE VENTRICLE PHYSIOLOGY AFTER FONTAN PALLIATION
Principal Investigator
Kevin D. Hill, MD, MS
Pediatric Cardiologist
Protocol Number
IRB: PRO00083031
NCT: NCT03013751
Phase
Phase III
ClinicalTrials.gov
Learn More About Clinical Trials at Duke
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698