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Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
This study is currently recruiting participants.
Verified by Radiant Research, June 2008
First Received: June 17, 2008   No Changes Posted
Sponsored by: Radiant Research
Information provided by: Radiant Research
ClinicalTrials.gov Identifier: NCT00701727
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe
Drug: Placebo
Phase IV

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol Metabolic Disorders
Drug Information available for: Ezetimibe
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study

Further study details as provided by Radiant Research:

Primary Outcome Measures:
  • fecal excretion of plasma-derived cholesterol [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • de novo cholesterol synthesis (DNC) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Cholesterol efflux rate (Ra cholesterol [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • RCT efflux [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Fasting lipid levels [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ezetimibe (10mg/day)for 7 weeks
Drug: ezetimibe
1 tablet,10mg, once a day, for 7 weeks
2: Placebo Comparator
Placebo control
Drug: Placebo
1 tablet, once a day, for 7 weeks

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701727

Contacts
Contact: Michael Kritschgau 312-494-2233 michaelKritschgau@radiantresearch.com
Contact: Laura Dowling 312-494-2339 LauraDowling@radiantresearch.com

Locations
United States, Illinois
Radiant Research Recruiting
Chicago, Illinois, United States, 60610
Principal Investigator: Michael H Davidson, MD, FACC            
Sponsors and Collaborators
Radiant Research
Investigators
Principal Investigator: Michael H Davidson, Md. FACC Radiant Research
  More Information

No publications provided

Responsible Party: Radiant Research ( Michael H. Davidson, MD, FACC )
Study ID Numbers: Ezetimibe RCT-001
Study First Received: June 17, 2008
Last Updated: June 17, 2008
ClinicalTrials.gov Identifier: NCT00701727     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiant Research:
metabolic diseases
metabolic disorder
dyslipidemias
lipid metabolism disorders

Study placed in the following topic categories:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Metabolic Diseases
Hyperlipidemias
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents
Hypercholesterolemia
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009