RecruitingPhase 3NCT05918211

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Sponsor

Mezzion Pharma Co. Ltd

Enrollment

436 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Single Ventricle Heart Disease

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 who have had the Fontan procedure.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Udenafil for people with single ventricle heart disease. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 12 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUdenafil

Active drug

DRUGPlacebo

Matching Placebo

Locations(40)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Children's

Little Rock, Arkansas, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Rady Children's Hospital

San Diego, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital of Colorado

Denver, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Nemours Children's Hospital

Wilmington, Delaware, United States

Childrens National Medical Center

Washington D.C., District of Columbia, United States

UF Health Shands Hospital

Gainesville, Florida, United States

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Hospital of Georgia

Augusta, Georgia, United States

Lurie Children's Hospital

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Children's Mercy Hospital Kansas City

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Children's Hospital and Medical Center

Omaha, Nebraska, United States

Mt. Sinai Children's Hospital

New York, New York, United States

New York-Presbyterian Children's Hospital

New York, New York, United States

Dana.Amaro@atriumhealth.org

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

MUSC Pediatric Research Group

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Sejong General Hospital

Bucheon-si, Gyeonggi-do, South Korea

Seoul National University Children's Hospital

Seoul, South Korea

Yonsei Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05918211

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