Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
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|ClinicalTrials.gov Identifier: NCT00701727|
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : April 18, 2011
Last Update Posted : April 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: ezetimibe Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study|
|Study Start Date :||June 2008|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
ezetimibe (10mg/day)for 7 weeks
1 tablet,10mg, once a day, for 7 weeks
Placebo Comparator: 2
1 tablet, once a day, for 7 weeks
- Fecal Excretion of Plasma-derived Cholesterol [ Time Frame: 7 weeks ]
(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:
- The composition of fecal neutral and acidic sterols will be measured as % of total.
- The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.
- The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).
- Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day.
- Change From Baseline in Total Cholesterol, From Fasting Plasma Samples [ Time Frame: 7 weeks ]plasma levels of total cholesterol
- de Novo Cholesterol Synthesis (DNC) [ Time Frame: 7 weeks ]Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.
- Cholesterol Efflux Rate (Ra Cholesterol) [ Time Frame: 7 weeks ]The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm - 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.
- Triglycerides (TG) [ Time Frame: 7 weeks ]Change from baseline in plasma triglycerides, measured in fasting blood samples
- Low-density Lipoprotein (LDL); [ Time Frame: 7 weeks ]Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples
- High-density Lipoprotein (HDL) [ Time Frame: 7 weeks ]Change from baseline in plasma HDL, measured in fasting blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701727
|United States, Illinois|
|Chicago, Illinois, United States, 60610|
|Principal Investigator:||Michael H Davidson, Md. FACC||Radiant Research|