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

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

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

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:

MedlinePlus related topics: Cholesterol Metabolic Syndrome

Drug Information available for: Cholest-5-en-3-ol (3beta)- Rosuvastatin calcium Rosuvastatin

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:

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 February 09, 2012