A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels
NCT00225615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2009-08-20
Summary
The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
Conditions
- Phenylketonurias
Interventions
- DRUG
-
sapropterin dihydrochloride
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Alex Dorenbaum, MD · BioMarin Pharmaceutical
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Completion
- 2006-06-30
Countries
- United States
Study Locations
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