Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome; Dyslipidemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paul J Nestel, MD, Principal Investigator, Affiliation: Baker Heart Research Institute
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Male.
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
Locations and Contacts
Research Site, Melbourne, Victoria, Australia
Additional Information
Starting date: August 2003
Last updated: October 16, 2005
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