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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240305
First Posted: October 18, 2005
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00240305     History of Changes
Other Study ID Numbers: 4522AS/0004
First Submitted: October 16, 2005
First Posted: October 18, 2005
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Metabolic Syndrome
Dyslipidaemia

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Dyslipidemias
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents