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Fontan Udenafil Exercise Longitudinal Assessment Trial

NCT02741115 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-06-17

Study results available
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Summary

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure.

Conditions

  • Single Ventricle Heart Disease

Interventions

DRUG

Udenafil

Active drug

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Mezzion Pharma Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Steve Paridon, MD · Children's Hospital of Phildelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-22
Primary Completion
2018-12-27
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02741115 on ClinicalTrials.gov