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| ID | Type | Description | Link |
|---|---|---|---|
| MSP-JV IISP #32031 |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin | Active Comparator | Simvastatin 40 mg daily |
|
| simvastatin/ezetimibe | Active Comparator | Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin | Drug | Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression | Measured using whole blood flow cytometry | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Inflammation | 6 weeks |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MICHAEL MILLER, MD | University of Maryland, College Park | Principal Investigator |
| VICTOR L. Serebruany, MD, PhD | President, HeartDrug Research LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland Medical Center |
Patients excluded included those unable to tolerate statin and/or ezetimibe treatment
All patients have been recruited and 15 have successfully completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin Then Simvastatin/Ezetimibe | Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. |
| FG001 | Simvastatin/Ezetimibe Then Simvastatin | Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
| |||||||||||||
| Washout (14 Days) |
| |||||||||||||
| Second Intervention (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin | Simvastatin 40 mg daily simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. |
| BG001 | Simvastatin/Ezetimibe |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression | Measured using whole blood flow cytometry | Based on power calculations | Posted | Mean | Standard Deviation | ng/dl | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin | Simvastatin 40 mg daily simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI symptoms | Gastrointestinal disorders | Non-systematic Assessment | Gas, bloating, change in bowel movements |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Miller | Univ Maryland | 410 328-6299 | mmiller@medicine.umaryland.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| ezetimibe/simvastatin | Drug | Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. |
|
|
| Baltimore |
| Maryland |
| 21202 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Biomarkers of Inflammation | Posted | Mean | Standard Deviation | mg/dl | 6 weeks |
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Simvastatin/Ezetimibe | Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. | 0 | 15 | 1 | 15 |
|
| Muscle symptoms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Aches, cramps |
|
| Fatigue | Psychiatric disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |