Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Single Ventricle
Interventions
DRUG

Tadalafil Citrate

If allocated to the treatment arm, the patient will be given tadalfil citrate, 0.8-1 mg/kg/day in 1 daily dose. Maximum dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.

DRUG

Sugar pill

If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a mixture of Ora-Sweet® and Ora-Plus® in a 1:1 ratio. All patients will receive drug for 20 days

Trial Locations (1)

84113

Primary Childrens Medical Center, Salt Lake City

All Listed Sponsors
lead

University of Utah

OTHER

NCT01291069 - Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients | Biotech Hunter | Biotech Hunter