Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
Information source: Radiant Research
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Radiant Research Official(s) and/or principal investigator(s):
Michael H Davidson, Md. FACC, Principal Investigator, Affiliation: Radiant Research
Overall contact:
Michael Kritschgau, Phone: 312-494-2233, Email: michaelKritschgau@radiantresearch.com
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 of 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.
Clinical Details
Official title: Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: fecal excretion of plasma-derived cholesterol
Secondary outcome: de novo cholesterol synthesis (DNC)Cholesterol efflux rate (Ra cholesterol RCT efflux Fasting lipid levels
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) 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
- LDL concentration between 130-200 mg/dL.
- TG concentration <350 mg/dL, inclusive
- 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%, AST/ALT>2X upper limit of normal,
abnormal TSH, fasting glucose >=126mg/dL
- renal impairment with 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
Locations and Contacts
Michael Kritschgau, Phone: 312-494-2233, Email: michaelKritschgau@radiantresearch.com
Radiant Research, Chicago, Illinois 60610, United States; Recruiting
Michael H Davidson, MD, FACC, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: December 2008
Last updated: June 17, 2008
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