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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00240266
First received: October 16, 2005
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00240266     History of Changes
Other Study ID Numbers: 4522AS/0003
Study First Received: October 16, 2005
Last Updated: November 18, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:
Metabolic Syndrome
Dyslipaemia

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

ClinicalTrials.gov processed this record on May 23, 2013