CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
ezetimibe +1 moredrug
Likely dose
ezetimibe 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00701727
NCT00701727Phase 4Completed
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Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study

Radiant Research·interventional·Posted Jun 19, 2008·Updated Apr 18, 2011

In Brief

A Phase 4 clinical trial evaluating ezetimibe and Placebo for Hypercholesterolemia. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2008
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.0 years ago

Interventions

ezetimibedrug

1 tablet,10mg, once a day, for 7 weeks

Placebodrug

1 tablet, once a day, for 7 weeks