At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
Udenafildrug
Likely dose
Udenafil 87.5 mgfrom 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.
Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study
In Brief
A Phase 3 clinical trial evaluating Udenafil for Single Ventricle Heart Disease. Completed, enrolled 88 participants across 17 sites in 2 countries.
Detailed Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSingle Ventricle Heart Disease
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartFeb 2018
Primary CompletionSep 2020
Study CompletionSep 2020
TodayJul 2026
First PostedFeb 13, 2018
Enrollment StartFeb 20, 2018
Primary CompletionSep 15, 2020
Study CompletionSep 16, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.4 years ago
Interventions
Udenafildrug
Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.