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NCT00332189 · ClinicalTrials.gov registry record · Phase 3
Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
NCT00332189: Completed Phase 3 study, sponsored by BioMarin Pharmaceutical.
NCT00332189 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00332189, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.
Primary Outcome
Safety was assessed with regards to the rate and type of AEs, clinically significant changes to vital signs and/or physical examination findings, and clinically significant changes in laboratory test results.
Interventions
- DRUG sapropterin dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00332189 record still lists
NCT00332189 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which sapropterin dihydrochloride is the first listed.
NCT00332189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00332189 about?
NCT00332189 is a clinical study titled "Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006". The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.
What is the current status of trial NCT00332189?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2006-07. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00332189?
The interventions under investigation include: sapropterin dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00332189?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00332189's enrollment target sits among peer trials
111 1655th of 2000 higher than 344 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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