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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00335699 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 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 |