A Extension Study of Udenafil in Adolescents



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - 18
Updated:1/19/2019
Start Date:January 2017
End Date:December 2019
Contact:Steve Paridon, MD
Email:paridon@email.chop.edu
Phone:2155903532

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A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

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.

This will be an open-label extension study. All enrolled subjects will be provided with
udenafil for the duration of the study. Subjects completing the Phase III FUEL study will be
eligible for recruitment. Additional subjects will be recruited as needed to ensure a minimum
of 300 total subjects enroll. Safety, pharmacodynamic and quality of life data will be
collected and analyzed.

Inclusion Criteria:

1. Males and females with Fontan physiology who participated in the FUEL trial or, if
they did not participate in FUEL, those who are 12 to less than 19 years of age at
enrollment.

2. Participant consent or parental/guardian consent and participant assent.

3. Participant fluent in English, Spanish, or Korean.

4. Current anti-platelet or anticoagulant therapy.

Exclusion Criteria:

1. Height < 132 cm.

2. Weight < 40 kg.

3. Hospitalization for acute decompensated heart failure within the last 12 months.

4. Current intravenous inotropic drugs.

5. Undergoing evaluation for heart transplantation or listed for transplantation.

6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last
three years, or a history of liver cirrhosis.

7. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein
stenosis resulting in a mean gradient of > 4 mm Hg between the regions proximal and
distal to the obstruction as measured by either catheterization or echocardiography.

8. Single lung physiology.

9. Maximal VO2 less than 50% of predicted for age and gender at enrollment.

10. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography
within six months prior to enrollment.

11. Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch
obstruction assessed by clinical echocardiography within six months prior to
enrollment.

12. Significant renal, hepatic, gastrointestinal or biliary disorders that could impair
absorption, metabolism or excretion of orally administered medications.

13. Inability to complete exercise testing at baseline screening.

14. History of PDE-5 inhibitor use (with the exception of FUEL participation) within 3
months before study onset.

15. Use of any other drug to treat pulmonary hypertension within 3 months before study
onset.

16. Known intolerance to oral udenafil.

17. Frequent use of medications or other substances that inhibit or induce CYP3A4.

18. Current use of alpha-blockers or nitrates.

19. Ongoing or planned participation in another research protocol that would either
prevent successful completion of planned study testing or invalidate its results.

20. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful
completion of planned study testing or would invalidate its results.

21. Cardiac care, ongoing or planned, at a non-study center that would impede study
completion.

22. For females: Pregnancy at the time of screening, pregnancy planned before study
completion, or refusal to use an acceptable method of contraception for study
duration.

23. Unable to abstain or limit intake of grapefruit juice during the duration of the
trial.

24. Refusal to provide written informed consent/assent.

25. In the opinion of the primary care physician, the subject is likely to be
non-compliant with the study protocol.

26. History of clinically significant thromboembolic event, as adjudicated by study
Investigators.
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New York, New York 10032
Principal Investigator: Marc Richmond, MD
Phone: 212-305-6575
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Bryan H Goldstein, MD
Phone: 513-636-7072
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South 34th Street
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 215-590-1000
Principal Investigator: David Goldberg, MD
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Ann Arbor, Michigan 48109
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
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13123 E 16th Ave
Aurora, Colorado 80045
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Phone: 720-777-4420
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Jonathan Rhodes, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Andrew M Atz, MD
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
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Phone: 832-826-1997
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Indianapolis, Indiana 46201
Principal Investigator: Mark Payne, MD
Phone: 317-278-6239
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Kansas City, Missouri 64108
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Los Angeles, California 90048
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Phone: 310-423-1153
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Salil Grinde, MD
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Phoenix, Arizona 85016
Principal Investigator: Tabitha G Moe, MD
Phone: 602-933-3366
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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501 6th Avenue South
Saint Petersburg, Florida 33701
Principal Investigator: Jeffrey Jacobs, MD
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Salt Lake City, Utah 84113
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San Diego, California 92123
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Seattle, Washington 98105
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555 University Avenue
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111 Michigan Ave NW
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Wilmington, Delaware 19803
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