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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00240305
First received: October 16, 2005
Last updated: March 13, 2009
Last verified: March 2009
History of Changes

October 16, 2005
March 13, 2009
April 2004
Not Provided
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
Same as current
Complete list of historical versions of study NCT00240305 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Dyslipidemia
Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2006
Not Provided

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
Male
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00240305
4522AS/0004
Not Provided
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Gerald F. Watts, BSc PhD MD University Department of Medicine, Royal Perth Hospital, University of Western Australia
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP