COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
- Registration Number
- NCT00654485
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 940
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Rosuvastatin Rosuvastatin 2 Atorvastatin Atorvastatin
- Primary Outcome Measures
Name Time Method Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome. At 6 & 12 weeks
- Secondary Outcome Measures
Name Time Method Modification of other lipids and lipoproteins At 6 & 12 weeks Modification of insulin resistance, inflammatory markers & glucose metabolism At 6 & 12 weeks Safety: adverse events & abnormal laboratory markers At 6 & 12 weeks