Status:
COMPLETED
Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
Detailed Description
1. To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrom...
Eligibility Criteria
Inclusion
- Men and women greater than or equal to 21 years of age
- 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:
- abdominal obesity, given as waist circumference for men \> 102 cm, and for women \> 88 cm
- triglycerides \> 150 mg/dL
- HDL cholesterol \< 40 mg/dL for men, and \< 50 mg/dL for women
- blood pressure \> 130/85 mm Hg
- fasting glucose \> 100 mg/dL
Exclusion
- Patients will be excluded for a history of bleeding diathesis
- drug or alcohol abuse
- prothrombin time greater than 1.5 times control
- platelet count \< 100,000/mm3
- hematocrit \< 25%
- creatinine \> 4.0 mg/dl
- surgery or angioplasty performed within 3 months or planned for the future
- history of gastrointestinal or other bleeding
- history of drug-induced disorders
- trauma, cancer, rheumatic diseases, coronary artery disease or stroke
- Patients participating in other investigational drug trials within one month of completion will be also excluded
- Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
- Patients treated with statins or aspirin within past four weeks
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00819403
Start Date
January 1 2009
End Date
November 1 2011
Last Update
January 14 2020
Active Locations (3)
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1
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21202
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287