Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

1. Men and women greater than or equal to 21 years of age

2. 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 Criteria:

1. Patients will be excluded for a history of bleeding diathesis

2. drug or alcohol abuse

3. prothrombin time greater than 1.5 times control

4. platelet count < 100,000/mm3

5. hematocrit < 25%

6. creatinine > 4.0 mg/dl

7. surgery or angioplasty performed within 3 months or planned for the future

8. history of gastrointestinal or other bleeding

9. history of drug-induced disorders

10. trauma, cancer, rheumatic diseases, coronary artery disease or stroke

11. Patients participating in other investigational drug trials within one month of completion will be also excluded

12. Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months

13. Patients treated with statins or aspirin within past four weeks