A Extension Study of Udenafil in Adolescents
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.
Study Start Date
January, 01 2017
Estimated Completion Date
- Drug: Udenafil
Mezzion Pharma Co. Ltd -- PHN-Udenafil-03
Mezzion Pharma Co. Ltd
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
2. Participant consent or parental/guardian consent and participant assent
3. Participant fluent in English, Spanish, or Korean
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
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
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
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
23. Unable to abstain or limit intake of grapefruit juice during the duration of the
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.
12 Years to 18 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (20)
|Boston Childrens Hospital - Boston, Massachusetts||2.6 miles||Jonathan Rhodes MD||617-355-3491||Jonathan.Rhodes@cardio.chboston.org|
|Childrens Hospital of New York - New York, New York||181.2 miles||Marc Richmond MDemail@example.com|
|Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania||270.8 miles||David Goldberg MDfirstname.lastname@example.org|
|Nemours Cardiac CenterAlfred I duPont Hospital for Children - Wilmington, Delaware||291.9 miles||Amanda Shillingford MD||302-651-6600||Amanda.Shillingford@nemours.org|
|Childrens National Medical Center - Washington, D.C., District of Columbia||392.8 miles||Anitha John MD PhD||202-476-2728||AnJohn@childrensnational.org|
|Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio||735.6 miles||Byran Goldstein MDemail@example.com|
|Riley Hospital for ChildrenHerman B Wells Center for Pediatric Research - Indianapolis, Indiana||802.8 miles||Mark Payne MD||317-278-6239||RPayne@iu.edu|
|Medical University of South Carolina - Charleston, South Carolina||821.2 miles||Ryan Butts MD||843-792-9146||Butts@musc.edu|
|Childrens Hospital of Wisconsin - Milwaukee, Wisconsin||862.1 miles||Salil Grinde MD||708-204-2963||SGrinde@chw.org|
|Childrens Healthcare of Atlanta - Atlanta, Georgia||932.0 miles||Christopher Petit MD||404-785-1796||PetitC@kidsheart.com|
|Washington University St LouisStLouis Childrens Hospital - Saint Louis, Missouri||1,039.5 miles||Charles Canter MD||314-454-6095||Canter@kids.wusti.edu|
|Johns Hopkins All Childrens Heart Institute - Saint Petersburg, Florida||1,201.6 miles||Jeffrey Jacobs MD||727-767-6666||JeffJacobs@msn.com|
|Childrens Mercy Hospital Kansas City - Kansas City, Missouri||1,249.3 miles||Girish Shirali MD||816-234-3947||GsSirali@cmh.edu|
|Texas Childrens Hospital - Houston, Texas||1,609.9 miles||Daniel Penny MD PhD||832-826-1997||DjPenny@texaschildrens.org|
|Childrens Hospital Colorado - Aurora, Colorado||1,759.8 miles||Michael V DiMaria MD||720-777-4420||Michael.DiMaria@childrenscolorado.org|
|Primary Childrens Medical HospitalDept of Pediatric Cardiology - Salt Lake City, Utah||2,093.2 miles||Shaji C Menon MD||801-662-5400||Shaji.Menon@hsc.utah.edu|
|Phoenix Childrens HospitalChildrens Heart Center at Phoenix Childrens Hospital - Phoenix, Arizona||2,294.8 miles||Tabitha G Moe MD||602-933-3366||TMoe@phoenixchildrens.com|
|Seattle Childrens Hosptial - Seattle, Washington||2,487.2 miles||Matthew Files MD||206-987-1787||Matthew.Files@seattlechildrens.org|
|Rady Childrens Hospital - San Diego, California||2,579.1 miles||Christopher Davis MD PhD||858-966-5855||CDavis@rchsd.org|
|CedarsSinai Heart Institute - Los Angeles, California||2,601.4 miles||Ruchira Garg MD||310-423-1153||Ruchira.Garg@cshs.org|