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NCT00225615 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT00225615 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 100 participants.
The verdict
NCT00225615, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
Interventions
- DRUG sapropterin dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00225615
The ClinicalTrials.gov registry entry for NCT00225615 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sapropterin dihydrochloride is the first listed.
NCT00225615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00225615 about?
NCT00225615 is a clinical study titled "A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels". The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
What is the current status of trial NCT00225615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2005-11. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00225615?
The interventions under investigation include: sapropterin dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00225615?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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