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A Extension Study of Udenafil in Adolescents

NCT03013751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-12-09

Study results available
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Summary

This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.

Conditions

  • Functional Single Ventricle Heart Disease

Interventions

DRUG

Udenafil

Active drug

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 Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2019-12-30
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea

Study Locations

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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 NCT03013751 on ClinicalTrials.gov