Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia; Metabolic Syndrome

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240266

4522AS/0003

Details and patient eligibility

About

The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• males aged 45-65
• insulin resistance
• central obesity
• LDL-C <6 mmol/L
• plasma triglycerides >=1.7 and ≤5.5 mmol/L
• HDL-C ≤1.2 mmol/L.

Exclusion criteria

• total cholesterol >7mmol/L
• pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind