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NCT00532844 · ClinicalTrials.gov registry record · Phase 2
A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
A Phase 2 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00532844 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 52 participants.
The verdict
NCT00532844, a Phase 2 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone.
Interventions
- DRUG Sapropterin Dihydrochloride
- DRUG Sapropterin Dihydrochloride and Vitamin C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00532844
The ClinicalTrials.gov registry entry for NCT00532844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 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 2 interventions - of which Sapropterin Dihydrochloride is the first listed.
NCT00532844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00532844 about?
NCT00532844 is a clinical study titled "A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction". This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and saprop...
What is the current status of trial NCT00532844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2007-09. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00532844?
The interventions under investigation include: Sapropterin Dihydrochloride (DRUG), Sapropterin Dihydrochloride and Vitamin C (DRUG).
Who is sponsoring clinical trial NCT00532844?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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