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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: Completed Phase 2 study, sponsored by BioMarin Pharmaceutical.
NCT00532844 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma BH4 concentration area under the curve (AUC0-12 hrs) at the end of each regimen in subjects with endothelial dysfunction.
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 |
What the finished NCT00532844 record still lists
NCT00532844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Sapropterin Dihydrochloride is the first listed.
NCT00532844 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00532844's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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