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NCT00104260 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria
A Phase 2 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT00104260 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 700 participants.
The verdict
NCT00104260, a Phase 2 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to Phenoptin™ treatment with a reduction in blood Phe level.
Interventions
- DRUG sapropterin dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00104260
The ClinicalTrials.gov registry entry for NCT00104260 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 700 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.
NCT00104260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00104260 about?
NCT00104260 is a clinical study titled "Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria". The primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to e...
What is the current status of trial NCT00104260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2004-12. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00104260?
The interventions under investigation include: sapropterin dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00104260?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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