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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)

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ClinicalTrials.gov Identifier: NCT00240266
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

October 16, 2005
October 18, 2005
November 19, 2010
August 2003
November 2004   (Final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00240266 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Dyslipidemia
Drug: Rosuvastatin
Other Name: Crestor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Same as current
December 2004
November 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
45 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00240266
4522AS/0003
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Paul J Nestel, MD Baker Heart Research Institute
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP