Back to resultsStudy of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Primary Purpose
Metabolic Syndrome, Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Dyslipaemia
Eligibility Criteria
Inclusion Criteria: Signed informed consent males aged 45-65 insulin resistance central obesity LDL-C <6 mmol/L plasma triglycerides >=1.7 and ≤5.5 mmol/L HDL-C ≤1.2 mmol/L. Exclusion Criteria: total cholesterol >7mmol/L pre-existing cardiovascular disease, diabetes, proteinuria or renal failure
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.
Secondary Outcome Measures
Determine the effect of treatment with rosuvastatin on:
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
- plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT.
- plasma concentration of preβ1-HDL.
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00240266
Brief Title
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Official Title
A Randomised, Double-blind, Placebo-controlled, Crossover Pilot Study to Define the High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Dyslipidemia
Keywords
Metabolic Syndrome, Dyslipaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Primary Outcome Measure Information:
Title
Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.
Secondary Outcome Measure Information:
Title
Determine the effect of treatment with rosuvastatin on:
Title
- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
Title
- plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT.
Title
- plasma concentration of preβ1-HDL.
Title
- plasma concentration of LDL cholesterol, HDL-C and apoA-1.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
males aged 45-65
insulin resistance
central obesity
LDL-C <6 mmol/L
plasma triglycerides >=1.7 and ≤5.5 mmol/L
HDL-C ≤1.2 mmol/L.
Exclusion Criteria:
total cholesterol >7mmol/L
pre-existing cardiovascular disease, diabetes, proteinuria or renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Nestel, MD
Organizational Affiliation
Baker Heart Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
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