Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Atorvastatin; Drug: Simvastatin; Drug: Rosuvastatin

• 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

Study Timeline

• Study Start: 2002-06
• Study Completion: 2004-09
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

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