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NCT00701727 · ClinicalTrials.gov registry record · Phase 4
Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
A Phase 4 study, sponsored by Radiant Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00701727: Completed Phase 4 study, sponsored by Radiant Research.
NCT00701727 is a Phase 4 study that has completed, run by Radiant Research. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00701727, a Phase 4 study, has completed, sponsored by Radiant Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a prospective, placebo-controlled, cross-over trial comparing the the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with secondary hypotheses that there will be a significant increase in de novo cholesterol synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and increase global RCT.
Primary Outcome
(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion: 1. The composition of fecal neutral and acidic sterols will be measured as % of total. 2. The excretion rate of fecal neutral and acidic sterols will be measured as mg/day. 3. The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE). 4. Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated a
Interventions
- DRUG Placebo
- DRUG ezetimibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 4 |
What the finished NCT00701727 record still lists
NCT00701727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00701727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00701727 about?
NCT00701727 is a clinical study titled "Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study". This is a prospective, placebo-controlled, cross-over trial comparing the the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women diagnosed with hypercholester...
What is the current status of trial NCT00701727?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2008-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00701727?
The interventions under investigation include: Placebo (DRUG), ezetimibe (DRUG).
Who is sponsoring clinical trial NCT00701727?
This trial is sponsored by Radiant Research, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00701727's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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