A 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.

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

Conditions

Metabolic Syndrome, Dyslipidemia

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further Details

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.

Study Start

April 2004

Eligibility & Criteria

• Ages Eligible for Study: 30 Years – 70 Years
• Genders Eligible for Study: Male
• Accepts Healthy Volunteers

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

Total Enrolment

15

Contact Details

Australian Locations:

• Perth, Western Australia

AstraZeneca Australia