Official Title: “A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%”

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2005

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
• Drug: Atorvastatin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rosuvastatin
• Active Comparator: 2
  • Atorvastatin

Primary Measures

• Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
  • Time Frame: At 6 & 12 weeks
    

Secondary Measures

• Modification of other lipids and lipoproteins
  • Time Frame: At 6 & 12 weeks
    
• Modification of insulin resistance, inflammatory markers & glucose metabolism
  • Time Frame: At 6 & 12 weeks
    
• Safety: adverse events & abnormal laboratory markers
  • Time Frame: At 6 & 12 weeks
    

Inclusion Criteria:

• Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
• Fasting low density lipoprotein cholesterol level of > 130 mg/dL.
• Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
• Not previously taken statins.

Exclusion Criteria:

• The use of lipid lowering drugs or dietary supplements after Visit 1
• Active arterial disease eg Unstable angina, or recent arterial surgery
• Blood lipid levels above the limits defined in the protocol
• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Prof. Anton Stalenhoef Principal Investigator University Medical Centre, The Netherlands  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654485

Study ID Number: 4522IL/0069

ClinicalTrials.gov Identifier: NCT00654485

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products