CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Udenafildrug
Likely dose
Not stated in 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/NCT02201342
NCT02201342Phase 2Completed
CompareCT.gov

A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Mezzion Pharma Co. Ltd·interventional·Posted Jul 28, 2014·Updated May 6, 2025

In Brief

A Phase 2 clinical trial evaluating Udenafil for Single Ventricle Heart Disease After Fontan Surgery. Completed, enrolled 36 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSingle Ventricle Heart Disease After Fontan Surgery
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.9 years ago

Interventions

Udenafildrug

Drug