Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
Phase 3
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00654173
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4444
Inclusion Criteria
- Member of managed care plan for hypercholesterolemia
- Fasting blood lipid levels as defined by the protocol
- Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease
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 3 Atorvastatin Atorvastatin 2 Simvastatin Simvastatin 1 Rosuvastatin Rosuvastatin
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin. 6 weeks
- Secondary Outcome Measures
Name Time Method Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin 6 & 12 weeks Safety: adverse events & abnormal laboratory markers 6 & 12 weeks