A Extension Study of Udenafil in Adolescents

Description

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

February 2019

Interventions

  • Drug: Udenafil

Study ID

Mezzion Pharma Co. Ltd -- PHN-Udenafil-03

Status

Unknown

Trial ID

NCT03013751

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Mezzion Pharma Co. Ltd

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

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.

Gender

All

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (20)

Study Location Distance Name Phone Email
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 MD 212-305-6575 mr2306@cumc.columbia.edu
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles David Goldberg MD 267-426-8143 goldbergda@email.chop.edu
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 MD 513-636-7072 bryan.goldstein@cchmc.org
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

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.