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

Official Title: “A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.”

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

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
• Drug: Simvastatin
• Drug: Atorvastatin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rosuvastatin
• Active Comparator: 2
  • Simvastatin
• Active Comparator: 3
  • Atorvastatin

Primary Measures

• Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
  • Time Frame: 6 weeks
    

Secondary Measures

• Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
  • Time Frame: 6 & 12 weeks
    
• Safety: adverse events & abnormal laboratory markers
  • Time Frame: 6 & 12 weeks
    

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

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Alex Gold, MD Principal Investigator AstraZeneca  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654173

Study ID Number: 4522US/0003

ClinicalTrials.gov Identifier: NCT00654173

Health Authority: United States: Food and Drug Administration