ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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.

Sponsored by: 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

MedlinePlus related topics:   Cholesterol   

ChemIDplus related topics:   Rosuvastatin    Rosuvastatin calcium   

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

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

  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


Publications indexed to this study:

Study ID Numbers:   4522AS/0004
First Received:   October 16, 2005
Last Updated:   December 6, 2006
ClinicalTrials.gov Identifier:   NCT00240305
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:
Metabolic Syndrome  
Dyslipidaemia  

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




Links to all studies - primarily for crawlers