Official Title: “A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES)”

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.

Study Type: Interventional

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

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
• Drug: Atorvastatin

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Low density lipoproteins cholesterol levels
  • Time Frame: 6 weeks
    

Secondary Measures

• Other blood lipid level changes
  • Time Frame: 6 weeks
    
• Safety: adverse events & abnormal laboratory markers
  • Time Frame: 6 weeks
    

Inclusion Criteria:

• Fasting low density lipoprotein level as defined by the protocol.
• Self described African American race
• Fasting triglyceride level as defined by 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
• 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 Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Keith Ferdinand Principal Investigator Heartbeats Life Centre, New Orleans, USA  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653744

Study ID Number: 4522US/0002

ClinicalTrials.gov Identifier: NCT00653744

Health Authority: United States: Food and Drug Administration