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Sponsored by: |
BioMarin Pharmaceutical |
Information provided by: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00225615 |
The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
Condition | Intervention | Phase |
Phenylketonurias |
Drug: sapropterin dihydrochloride |
Phase III |
Genetics Home Reference related topics: | argininosuccinic aciduria citrullinemia N-acetylglutamate synthase deficiency ornithine translocase deficiency phenylketonuria tetrahydrobiopterin deficiency |
MedlinePlus related topics: | Phenylketonuria |
ChemIDplus related topics: | Phenylalanine Sapropterin Sapropterin dihydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Study Completion Date: | June 2006 |
Ages Eligible for Study: | 8 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Los Angeles, California, United States | |||||
Oakland, California, United States | |||||
San Jose, California, United States | |||||
Sacramento, California, United States | |||||
United States, Connecticut | |||||
New Haven, Connecticut, United States | |||||
United States, Georgia | |||||
Atlanta, Georgia, United States | |||||
United States, Illinois | |||||
Chicago, Illinois, United States | |||||
United States, Minnesota | |||||
Minneapolis, Minnesota, United States | |||||
United States, Missouri | |||||
St. Louis, Missouri, United States | |||||
United States, New York | |||||
New York, New York, United States | |||||
United States, Oregon | |||||
Portland, Oregon, United States | |||||
United States, Texas | |||||
Dallas, Texas, United States | |||||
United States, Utah | |||||
Salt Lake City, Utah, United States | |||||
United States, Wisconsin | |||||
Madison, Wisconsin, United States |
BioMarin Pharmaceutical |
Study Chair: | Alex Dorenbaum, MD | BioMarin Pharmaceutical |
BioMarin Pharmaceutical Inc website 
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Study ID Numbers: | PKU-004 |
First Received: | September 22, 2005 |
Last Updated: | April 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00225615 |
Health Authority: | United States: Food and Drug Administration |
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