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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00654485 |
The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.
Condition | Intervention | Phase |
---|---|---|
Metabolic Syndrome |
Drug: Rosuvastatin Drug: Atorvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10% |
Estimated Enrollment: | 940 |
Study Start Date: | May 2002 |
Study Completion Date: | February 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:
Study ID Numbers: | 4522IL/0069, D3560C00069 |
Study First Received: | April 3, 2008 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00654485 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Finland: National Agency for Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Slovakia: State Institute for Drug Control; United States: Food and Drug Administration |
Cholesterol hypercholesterolemia low density lipoproteins metabolic syndrome Rosuvastatin |
Antimetabolites Rosuvastatin Antilipemic Agents Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Atorvastatin |
Antimetabolites Disease Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Pharmacologic Actions Pathologic Processes Rosuvastatin Syndrome Therapeutic Uses Atorvastatin |