CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Sildenafil +3 moredrug
Likely dose
Sildenafil 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00964782
NCT00964782Phase 4Completed

The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Milton S. Hershey Medical Center·interventional·Posted Aug 25, 2009·Updated Mar 26, 2019

In Brief

A Phase 4 clinical trial evaluating Sildenafil, Placebo, and 2 other interventions for Fontan Circulation. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2009
Enrollment StartAug 1, 2009
Primary CompletionMay 24, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.9 years ago

Interventions

Sildenafildrug

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.

Placebodrug

Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.

Sildenafil 2drug

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).

Placebo 2drug

Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).