STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges
Phase 3
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00654537
- Lead Sponsor
- AstraZeneca
- Brief Summary
To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5625
Inclusion Criteria
- Discontinuation of all previous lipid lowering therapy.
- Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1.
- Other lipid parameters as specified in the protocol.
Exclusion Criteria
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Abnormal laboratory parameters as defined in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Pravastatin Pravastatin 2 Atorvastatin Atorvastatin 1 Rosuvastatin Rosuvastatin 4 Simvastatin Simvastatin
- Primary Outcome Measures
Name Time Method Percentage change in low density lipoprotein cholesterol. 4 & 6 weeks
- Secondary Outcome Measures
Name Time Method Percentage change in other lipid parameters as defined by the protocol 6 weeks Safety evaluation 6 weeks