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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00335699 |
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: Rosuvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-Week, Randomised, Open-Label, Parallel Group, Multi-Centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Non-Diabetic Metabolic Syndrome Subjects With Raised LDL-C |
Estimated Enrollment: | 370 |
Study Start Date: | August 2005 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Metabolic syndrome patient; Presence of 3 or more of the following:
Elevated LDL-C concentrations reported within 4 weeks of visit 1 as follows;
Exclusion Criteria:
Korea, Republic of | |
Research Site | |
Pusan, Korea, Republic of | |
Research Site | |
DaeGu, Korea, Republic of | |
Research Site | |
JinJu, Korea, Republic of | |
Research Site | |
IkSan, Korea, Republic of | |
Research Site | |
KwangJu, Korea, Republic of | |
Research Site | |
JeonJu, Korea, Republic of | |
Research Site | |
Ulsan, Korea, Republic of |
Study Director: | AstraZeneca Korea Medical Director, MD | AstraZeneca |
Study ID Numbers: | D3560L00053, KREST |
Study First Received: | June 9, 2006 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00335699 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Hypercholesterolemia with nondiabetic metabolic syndrome |
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 Disease Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Pharmacologic Actions Pathologic Processes Rosuvastatin Therapeutic Uses Syndrome Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |