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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240266
First Posted: October 18, 2005
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome Dyslipidemia Drug: Rosuvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 15
Study Start Date: August 2003
Study Completion Date: December 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin
    Other Name: Crestor
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240266


Locations
Australia, Victoria
Research Site
Melbourne, Victoria, Australia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Paul J Nestel, MD Baker Heart Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00240266     History of Changes
Other Study ID Numbers: 4522AS/0003
First Submitted: October 16, 2005
First Posted: October 18, 2005
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Metabolic Syndrome
Dyslipaemia

Additional relevant MeSH terms:
Metabolic Syndrome X
Dyslipidemias
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents


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