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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00653744 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia Dyslipidaemia |
Drug: Rosuvastatin Drug: Atorvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 1700 |
Study Start Date: | March 2002 |
Study Completion Date: | July 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Rosuvastatin
|
Drug: Rosuvastatin |
2: Active Comparator
Atorvastatin
|
Drug: Atorvastatin |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Elisabeth Björk ) |
Study ID Numbers: | 4522US/0002, D3560L00022 |
Study First Received: | March 26, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00653744 |
Health Authority: | United States: Food and Drug Administration |
Cholesterol low density lipoproteins dyslipidaemia Rosuvastatin |
Crestor Atorvastatin Lipitor African American |
Rosuvastatin Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |