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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00166504 |
This is an efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: ezetimibe (+) simvastatin Drug: atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Open-Label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia |
Enrollment: | 203 |
Study Start Date: | October 2005 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ezetimibe (+) simvastatin
simvastatin/ezetimibe 10/20 mg
|
2: Active Comparator |
Drug: atorvastatin
atorvastatin 10 mg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_070, MK0653A-092 |
Study First Received: | September 9, 2005 |
Results First Received: | October 13, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00166504 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Antimetabolites Hyperlipidemias Metabolic Diseases Simvastatin Antilipemic Agents Ezetimibe Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Metabolic Disorder Dyslipidemias Atorvastatin Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Enzyme Inhibitors Ezetimibe |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |