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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00551876 |
The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: MK0653, ezetimibe / Duration of Treatment: 30 Weeks Drug: Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones |
Estimated Enrollment: | 250 |
Study Start Date: | December 2001 |
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2006_554 |
Study First Received: | October 29, 2007 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00551876 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Simvastatin Diabetes Mellitus, Type 2 Diabetes Mellitus 2,4-thiazolidinedione |
Endocrine System Diseases Ezetimibe Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |