STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

Verified by: AstraZeneca, March 2009
First Received: April 3, 2008 | Last Updated: March 13, 2009 | Phase: Phase 3 | Start Date: April 2001
Overall Status: Completed | Estimated Enrollment: 5625
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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...

Brief Summary

Official Title: “A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Rosuvastatin
  • Active Comparator: 2
    • Atorvastatin
  • Active Comparator: 3
    • Pravastatin
  • Active Comparator: 4
    • Simvastatin

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage change in low density lipoprotein cholesterol.
    • Time Frame: 4 & 6 weeks

Secondary Measures

  • Percentage change in other lipid parameters as defined by the protocol
    • Time Frame: 6 weeks
  • Safety evaluation
    • Time Frame: 6 weeks

Criteria for Participation in this Clinical Trial

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.

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

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Eleanor Miller, MD Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654537

Study ID Number: 4522IL/0065

ClinicalTrials.gov Identifier: NCT00654537

Health Authority: United States: Food and Drug Administration

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