Trials / Completed
CompletedNCT00225615
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (planned)
- Sponsor
- BioMarin Pharmaceutical · Industry
- Sex
- All
- Age
- 8 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sapropterin dihydrochloride |
Timeline
- Start date
- 2005-11-01
- Completion
- 2006-06-01
- First posted
- 2005-09-26
- Last updated
- 2009-08-20
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00225615. Inclusion in this directory is not an endorsement.