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Completed

NCT Number: NCT00240266

Study of 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.

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Key information

Conditions

Metabolic Syndrome Dyslipidemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

Primary outcomes

  1. 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 outcomes

  1. Determine the effect of treatment with rosuvastatin on:

  2. - cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.

  3. - 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.

  4. - plasma concentration of preβ1-HDL.

  5. - plasma concentration of LDL cholesterol, HDL-C and apoA-1.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 18, 2005
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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