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

Metabolic Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240266
• Other study ID #: 4522AS/0003
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2005
• Last updated: November 18, 2010
• Start date: August 2003
• Est. completion date: December 2004

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
Australia	Research Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the effect of treatment with rosuvastatin on:
Secondary	- cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.
Secondary	- 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.
Secondary	- plasma concentration of preß1-HDL.
Secondary	- plasma concentration of LDL cholesterol, HDL-C and apoA-1.