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

Phase 3

Completed

• Conditions: Metabolic Syndrome; Dyslipidemia

• Registration Number: NCT00240305
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-10-16
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Study Completion: 2006-05
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇦🇺 Perth, Western Australia, Australia