Official Title: “An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.”

The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2004

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
  • Time Frame: 16 weeks
    

Secondary Measures

• Percentage change in other cholesterol & triglyceride measures
  • Time Frame: 16 weeks
    
• Safety evaluation
  • Time Frame: 8 & 16 weeks
    
• To compare the efficacy of rosuvastatin with atorvastatin and simvastatin

Inclusion Criteria:

• Discontinuation of all cholesterol lowing drugs, including dietary supplements.
• Documented history of, or high risk of coronary heart disease or other established atherosclerotic 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
• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
• Abnormal laboratory parameters as defined in the protocol.

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 Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Joel Raichlen Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654407

Study ID Number: 4522IL/0068

ClinicalTrials.gov Identifier: NCT00654407

Health Authority: United States: Food and Drug Administration