Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00701727

Run by

Radiant Research

People needed

31

Starts

2008-06-01

Expected to finish

2009-03-01

Last updated by the study team

2011-04-18

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• male, non-smoker, 21-75 years of age
• female, non-smoker, 40-75 years of age
• post-menopausal women, as defined by lack of menses for at least 2 years and age >55, OR history of documented bilateral oophorectomy, confirmed with an elevated FSH at screening
• low-density lipoprotein (LDL) concentration between 130-200 mg/dL.
• triglyceride (TG) concentration <350 mg/dL, inclusive
• high-density lipoprotein (HDL) between 30-60 mg/dL for men and 40 -70 mg/dL for women
• ability to give informed consent

You may not qualify if…

• Subject has history of diabetes mellitus, active hepatitis, gall bladder disease, gastric or ileal bypass surgery, irritable bowel syndrome, and gastrointestinal disorder/condition associated with malabsorption, or clinically significant abnormalities on screening (prestudy) physical examination of laboratory tests.
• Screening laboratory tests with hematocrit <30%, aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2*upper limit of normal, abnormal thyroid-stimulating hormone (TSH), fasting glucose >=126mg/dL
• renal impairment with creatinine clearance (CRCl)<80ml/min
• treatment within the last 2 months with drugs known to alter lipid metabolism including beta blockers, thiazide diuretics, bile acid resins, statins, ezetimibe, niacin, fibrates, plant stanol esters (eg Benecol,phyto sterols) and fishoils
• history of known coronary heart disease (CHD), stroke or prior revascularization procedure or peripheral vascular disease
• history of allergy to egg or soy products
• current or recent (past 12 months) of drug abuse or alcohol abuse. Alcohol use must be limited to no more than 2 drinks/day (1 drink=12 oz beer, 5 oz wine, or 1.5 oz hard liquor). Subject must be willing to avoid large day-to-day fluctuations in alcohol intake.
• participation in another clinical trial or exposure to any investigational agent within 30 days prior to Visit 1
• Individual has a condition the Principal Investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results, or put the subject at undue risk

Where it is running

• Radiant Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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