A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240305

Purpose

The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.

Condition	Intervention	Phase
Metabolic Syndrome Dyslipidemia	Drug: Rosuvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo Controlled, Crossover Dose-Ranging Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Determine the dose-related effect of treatment with rosuvastatin on production & fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), & on the plasma apoA-I, apoA-II & high-density lipoprotein cholesterol (HDL-C) c

Secondary Outcome Measures:

Determine the dose-related effect of treatment with rosuvastatin on cellular cholesterol efflux,total cholesterol, low-density lipoprotein cholesterol (LDL-C), non-LDL-C, triglyceride & pre1-HDL concentrations,HDL2,HDL3 cholesterol ratio
Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity
Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.

Estimated Enrollment:	15
Study Start Date:	April 2004
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Signed informed consent
male aged 30 to 70 years of age
LDL-C <6 mmol/L
HDL-C ≤1.2 mmol/L
at least 2 of the following:
insulin resistance (fasting glucose >6 mmol/L or insulin >10 mU/L or HOMA score >2.5)
central obesity (waist circumference >=94 cm).
plasma triglycerides >=1.7 and <4.5 mmol/L.
blood pressure >=130/ >=85 mm Hg or on drug treatment for hypertension

Exclusion Criteria:

LDL cholesterol >=6 mmol/L
pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease
apolipoprotein genotype E2/E2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240305

Locations

Australia, Western Australia
Research Site
Perth, Western Australia, Australia

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Gerald F. Watts, BSc PhD MD

University Department of Medicine, Royal Perth Hospital, University of Western Australia

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ooi EM, Watts GF, Chan DC, Chen MM, Nestel PJ, Sviridov D, Barrett PH. Dose-dependent effect of rosuvastatin on VLDL-apolipoprotein C-III kinetics in the metabolic syndrome. Diabetes Care. 2008 Aug;31(8):1656-61. Epub 2008 May 28.

Ooi EM, Barrett PH, Chan DC, Nestel PJ, Watts GF. Dose-dependent effect of rosuvastatin on apolipoprotein B-100 kinetics in the metabolic syndrome. Atherosclerosis. 2008 Mar;197(1):139-46. Epub 2007 Apr 9.

Study ID Numbers:	4522AS/0004
Study First Received:	October 16, 2005
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00240305 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:

Metabolic Syndrome
Dyslipidaemia

Additional relevant MeSH terms:

Antimetabolites
Disease
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Pathologic Processes
Rosuvastatin
Therapeutic Uses
Syndrome
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010