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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

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