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NCT00403494 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
A Phase 2 study of Intermittent Claudication, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT00403494: Completed Phase 2 study of Intermittent Claudication, sponsored by BioMarin Pharmaceutical.
NCT00403494 is a Phase 2 study of Intermittent Claudication that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 190 participants, roughly in line with the 199-participant average among 11 other Intermittent Claudication trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00403494, a Phase 2 study of Intermittent Claudication, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).
Primary Outcome
This is to assess the effect of oral sapropterin dihydrochloride versus placebo on peak walking time (PWT) in subjects with intermittent claudication (IC) caused by peripheral arterial disease (PAD).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sapropterin Dihydrochloride
Study Locations (20)
California
- - Sacramento
- - San Diego
- - Santa Ana
- - Santa Rosa
Other
- - Buenos Aires
- - Corrientes
- - Santa Fe
Florida
- - Clearwater
- - Jacksonville
Texas
- - Dallas
- - San Antonio
Virginia
- - Norfolk
- - Richmond
Arizona
- - Scottsdale
Georgia
- - Conyers
Indiana
- - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00403494 record still lists
NCT00403494 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 199-participant average among 11 other Intermittent Claudication trials with a reported enrollment target.
The record links to 1 condition, with Intermittent Claudication appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00403494 names 20 study sites across 12 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT00403494 about?
NCT00403494 is a clinical study titled "A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease". The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).
What is the current status of trial NCT00403494?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2006-12. Estimated completion is 2009-01.
What conditions does trial NCT00403494 study?
This clinical trial studies the following conditions: Intermittent Claudication.
What interventions are being tested in trial NCT00403494?
The interventions under investigation include: Placebo (OTHER), Sapropterin Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00403494?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00403494 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Intermittent Claudication
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00403494's enrollment target sits among peer trials
190 7th of 11 higher than 5 of 11 other Intermittent Claudication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intermittent Claudication 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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