Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

November 18, 2010 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Rosuvastatin

Study Type

Interventional

Enrollment

Phase

Phase 3

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

Australia
- Victoria
  - Melbourne, Victoria, Australia
    - Research Site

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

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Paul J Nestel, MD, Baker Heart Research Institute

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

August 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

October 16, 2005

First Submitted That Met QC Criteria

October 16, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

4522AS/0003

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.