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Completed Phase 3 Interventional Results available

Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness

ClinicalTrials.gov ID: NCT03430583

Public ClinicalTrials.gov record NCT03430583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

Study identification

NCT ID
NCT03430583
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Enrollment
88 participants

Conditions and interventions

Interventions

  • Udenafil Drug

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 19, 2018
Primary completion
Sep 14, 2020
Completion
Sep 15, 2020
Last update posted
Oct 13, 2025

2018 – 2020

United States locations

U.S. sites
16
U.S. states
16
U.S. cities
16
Facility City State ZIP Site status
Children's Hospital Colorado Aurora Colorado 80045
Nemours Cardiac Center/Alfred I. duPont Hospital for Children Wilmington Delaware 19803
Children's National Medical Center Washington D.C. District of Columbia 20008
Children's Healthcare of Atlanta Atlanta Georgia 30322
Children's Mercy Hospital Kansas City Kansas 64108
Boston Children's Hospital Boston Massachusetts 02115
University of Michigan Congenital Heart Center Ann Arbor Michigan 48109-4204
Children's Mercy Hospital Kansas City Kansas City Missouri 64108
University of Nebraska Children's Hospital and Medical Center Omaha Nebraska 68114
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Medical University of South Carolina Charleston South Carolina 29425
Vanderbilt University Medical Center Nashville Tennessee 37232
Texas Children's Hospital Houston Texas 77030
Primary Children's Medical Hospital/Dept. of Pediatric Cardiology Salt Lake City Utah 84113
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03430583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03430583 live on ClinicalTrials.gov.

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