Status:
COMPLETED
Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
Lead Sponsor:
Radiant Research
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief 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 o...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00701727
Start Date
June 1 2008
End Date
March 1 2009
Last Update
April 18 2011
Active Locations (1)
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1
Radiant Research
Chicago, Illinois, United States, 60610