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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00654225 |
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 South Asian 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 and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects. |
Estimated Enrollment: | 2340 |
Study Start Date: | October 2002 |
Study Completion Date: | March 2005 |
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/0006, D3560L00026 |
Study First Received: | March 26, 2008 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00654225 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Cholesterol low density lipoproteins dyslipidaemia Rosuvastatin |
Crestor Atorvastatin Lipitor South Asian |
Antimetabolites Rosuvastatin Metabolic Diseases Hyperlipidemias Antilipemic Agents Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Metabolic Disorder Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Pharmacologic Actions Rosuvastatin Therapeutic Uses Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |