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NCT00863265 · ClinicalTrials.gov registry record · Early Phase 1
Phytosterols, Ezetimibe, and Cholesterol Metabolism
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT00863265: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT00863265 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00863265, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover trial the effects of placebo, ezetimibe treatment and ezetimibe plus phytosterol treatment will be measured.
Primary Outcome
Milligrams of fecal cholesterol and cholesterol metabolites excreted per day
Interventions
- OTHER Placebo
- DRUG Ezetimibe
- OTHER Phytosterols + ezetimibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-02 |
| Phase | Early Phase 1 |
What the finished NCT00863265 record still lists
NCT00863265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00863265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00863265 about?
NCT00863265 is a clinical study titled "Phytosterols, Ezetimibe, and Cholesterol Metabolism". Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-con...
What is the current status of trial NCT00863265?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2009-06. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00863265?
The interventions under investigation include: Placebo (OTHER), Ezetimibe (DRUG), Phytosterols + ezetimibe (OTHER).
Who is sponsoring clinical trial NCT00863265?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00863265's enrollment target sits among peer trials
22 1104th of 2000 higher than 872 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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