Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

Completed · Phase 4

Conditions studied: Metabolic Syndrome

In brief

To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

Key facts

Study ID

NCT00819403

Run by

University of Maryland, Baltimore

People needed

15

Starts

2009-01-01

Expected to finish

2011-11-01

Last updated by the study team

2020-01-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Maryland Health Care System — Baltimore, Maryland, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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