Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
|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|
|Actual Primary Completion Date :||March 2009|
|Actual 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
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|