Fontan Udenafil Exercise Longitudinal Assessment Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 22, 2016

Primary Completion Date

December 27, 2018

Study Completion Date

April 30, 2019

Conditions
Single Ventricle Heart Disease
Interventions
DRUG

Udenafil

Active drug

DRUG

Placebo

Matching Placebo

Trial Locations (30)

10032

Children's Hospital of New York, New York

14754

Sejong General Hospital, Bucheon-si

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Nemours Cardiac Center/Alfred I. duPont Hospital for Children, Wilmington

20008

Children's National Medical Center, Washington D.C.

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta, Atlanta

33701

Johns Hopkins All Children's Heart Institute, St. Petersburg

37232

Vanderbilt University Medical Center, Nashville

43205

Nationwide Children's Hosptial, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46201

Riley Hospital for Children/Herman B. Wells Center for Pediatric Research, Indianapolis

53226

Children's Hospital of Wisconsin, Milwaukee

63110

Washington University St. Louis/St.Louis Children's Hospital, St Louis

64108

Children's Mercy Hospital Kansas City, Kansas City

68114

University of Nebraska Children's Hospital and Medical Center, Omaha

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Medical Hospital/Dept. of Pediatric Cardiology, Salt Lake City

85016

Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

90048

Cedars/Sinai Heart Institute, Los Angeles

92123

Rady Children's Hospital, San Diego

98105

Seattle Children's Hosptial, Seattle

02115

Boston Children's Hospital, Boston

48109-4204

University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital, Ann Arbor

T6G 2B7

Stollery Children's Hospital - University of Alberta, Edmonton

ON M5G 1X8

The Hospital for Sick Children, Toronto

110-744

Seoul National University Children's Hospital, Seoul

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Mezzion Pharma Co. Ltd

INDUSTRY

NCT02741115 - Fontan Udenafil Exercise Longitudinal Assessment Trial | Biotech Hunter | Biotech Hunter