Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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The study will compare the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) on: 1) the efficiency of endogenous (plasma-derived) cholesterol excretion (%/day) 2) de novo cholesterol (DNC) synthesis ((%/day) 3) cholesterol efflux from tissues into blood (Ra), and 4) global RCT (efflux from tissues that is excreted as fecal sterols). Subjects will receive 7 weeks of either treatment or placebo, undergo RCT and DNC measurements, taking 10 days, then cross-over to the alternate placebo or treatment for an additional 7 weeks, followed by a second set of RCT and DNC measurements.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

ezetimibe (10mg/day)for 7 weeks

Group Type EXPERIMENTAL

ezetimibe

Intervention Type DRUG

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

2

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet, once a day, for 7 weeks

Interventions

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ezetimibe

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

Intervention Type DRUG

Placebo

1 tablet, once a day, for 7 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes