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

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 III

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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)

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

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

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

Keywords provided by AstraZeneca:

Metabolic Syndrome

Dyslipaemia

Study placed in the following topic categories:

Rosuvastatin

Metabolic Diseases

Metabolic disorder

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Syndrome

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240266