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Sponsored by: |
BioMarin Pharmaceutical |
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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 |
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Phenylketonurias |
Drug: sapropterin dihydrochloride |
Phase III |
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 |
Study Chair: | Alex Dorenbaum, MD | BioMarin Pharmaceutical |
Study ID Numbers: | PKU-004 |
Study First Received: | September 22, 2005 |
Last Updated: | April 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00225615 |
Health Authority: | United States: Food and Drug Administration |
Phenylalanine Hydroxylase |
Metabolism, Inborn Errors Inborn amino acid metabolism disorder Metabolic Diseases Genetic Diseases, Inborn Amino Acid Metabolism, Inborn Errors Central Nervous System Diseases |
Brain Diseases, Metabolic, Inborn Phenylketonurias Metabolic disorder Brain Diseases Phenylketonuria Brain Diseases, Metabolic |
Nervous System Diseases |