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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Dyslipidemia

Metabolic Syndrome

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240305

4522AS/0004

Details and patient eligibility

About

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.

Sex

Male

Ages

30 to 70 years old

Volunteers

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