Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00104247 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT00104247 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 89 participants.
The verdict
NCT00104247, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.
Interventions
- DRUG sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00104247
The ClinicalTrials.gov registry entry for NCT00104247 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 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, 6R-BH4, tetrahydrobiopterin is the first listed.
NCT00104247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00104247 about?
NCT00104247 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels". The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.
What is the current status of trial NCT00104247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2005-03. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00104247?
The interventions under investigation include: sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin (DRUG).
Who is sponsoring clinical trial NCT00104247?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.