- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00701727
Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
March 14, 2011 updated by: Radiant Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60610
- Radiant Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
ezetimibe (10mg/day)for 7 weeks
|
1 tablet,10mg, once a day, for 7 weeks
|
Placebo Comparator: 2
Placebo control
|
1 tablet, once a day, for 7 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal Excretion of Plasma-derived Cholesterol
Time Frame: 7 weeks
|
(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Cholesterol, From Fasting Plasma Samples
Time Frame: 7 weeks
|
plasma levels of total cholesterol
|
7 weeks
|
de Novo Cholesterol Synthesis (DNC)
Time Frame: 7 weeks
|
Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.
|
7 weeks
|
Cholesterol Efflux Rate (Ra Cholesterol)
Time Frame: 7 weeks
|
The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr.
An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm - 12 noon).
This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.
|
7 weeks
|
Triglycerides (TG)
Time Frame: 7 weeks
|
Change from baseline in plasma triglycerides, measured in fasting blood samples
|
7 weeks
|
Low-density Lipoprotein (LDL);
Time Frame: 7 weeks
|
Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples
|
7 weeks
|
High-density Lipoprotein (HDL)
Time Frame: 7 weeks
|
Change from baseline in plasma HDL, measured in fasting blood samples
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael H Davidson, Md. FACC, Radiant Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 17, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Estimate)
April 18, 2011
Last Update Submitted That Met QC Criteria
March 14, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ezetimibe RCT-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Boryung Pharmaceutical Co., LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Ahn-Gook Pharmaceuticals Co.,LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
Clinical Trials on ezetimibe
-
Organon and CoCompletedCoronary Disease | Hypercholesterolemia
-
Organon and CoCompletedCoronary Disease | Hypercholesterolemia
-
Organon and CoCompletedCoronary Disease | Hypercholesterolemia
-
Organon and CoCompletedCoronary Disease | Hypercholesterolemia
-
Bronx VA Medical CenterCompletedHypercholesterolemiaUnited States
-
Cao YuRecruiting
-
The Affiliated Hospital of Qingdao UniversityCompleted
-
Karo Bio ABCompleted
-
Korea UniversityWithdrawn
-
Peking Union Medical College HospitalUnknownAtherosclerosisChina