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Sponsors and Collaborators: |
University of Maryland Merck |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00819403 |
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothromobosis compared to simvastatin alone in patients with the metabolic syndrome.
Condition | Intervention | Phase |
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Metabolic Syndrome |
Drug: simvastatin Drug: ezetimibe/simvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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simvastatin: Active Comparator
Simvastatin 40 mg daily
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Drug: simvastatin
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherthrombotic biomarker assessment will be studied.
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simvastatin/ezetimibe: Active Comparator
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherthrombotic biomarker assessment will be studied.
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Drug: ezetimibe/simvastatin
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherthrombotic biomarker assessment will be studied.
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Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
Exclusion Criteria:
Contact: MICHAEL MILLER, MD | 410 328-6299 | mmiller@medicine.umaryland.edu |
Contact: Cathy Winks | 410 328-6299 | cwinks@medicine.umaryland.edu |
Principal Investigator: | MICHAEL MILLER, MD | University of Maryland |
Study Director: | VICTOR L. Serebruany, MD, PhD | President, HeartDrug Research LLC |
Responsible Party: | University of Maryland Medical Center ( Michael Miller, MD, Director, Center for Preventive Cardiology, University of Maryland Medical Center ) |
Study ID Numbers: | H-28931 (UMMS-2009), MSP-JV IISP #32031 |
Study First Received: | January 7, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819403 |
Health Authority: | United States: Institutional Review Board |
triglycerides hypertension low hdl obesity |
Obesity Simvastatin Ezetimibe Hypertension |
Antimetabolites Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Syndrome Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |