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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.
Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference >40inches in men, >35 inches in women elevated triglycerides >150mg/dL reduced HDL <40mg/dL in men<50 in women elevated blood pressure >130mmHg systolic, or >85mmHg diastolic elevated fasting glucose >100mg/dL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin + Placebo Rosiglitazone | Active Comparator | Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily |
|
| Simvastatin + rosiglitazone | Active Comparator | Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug | 4 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in High-sensitivity C-reactive Protein | change in high-sensitivity C-reactive between baseline and 6 month | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Isoprostane | change in urinary isoprostane between baseline and 6 month | Baseline and 6 months |
| Change in Malondialdehyde | change in Malondialdehyde between baseline and 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Bakris, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | simvastatin 40 mg/day plus placebo |
| FG001 | Rosiglitazone | simvastatin 40 mg/day plus rosiglitazone 4 mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | simvastatin 40 mg/day plus placebo |
| BG001 | Rosiglitazone | simvastatin 40 mg/day plus rosiglitazone 4 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in High-sensitivity C-reactive Protein | change in high-sensitivity C-reactive between baseline and 6 month | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
|
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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 | Placebo | simvastatin 40 mg/day plus placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nonspecific muscle aches in lower extremities | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Bakris | University of Chicago | 773-702-7936 | bbrisky@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo Rosiglitazone | Drug | 1 tab daily |
|
|
| Simvastatin | Drug | 40 mg daily |
|
|
| Baseline and 6 months |
| Change in Office Systolic Blood Pressure | change in office systolic blood pressure between baseline and 6 month | Baseline and 6 months |
| Change in Office Diastolic Blood Pressure | change in office diastolic blood pressure between baseline and 6 month | Baseline and 6 months |
| Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure | change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month | Baseline and 6 months |
| Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure | change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month | Baseline and 6 months |
| Change in Low-density Lipoprotein | change in low-density lipoprotein between baseline and 6 month | Baseline and 6 months |
| Change in Triglycerides | change in Triglycerides between baseline and 6 month | Baseline and 6 months |
| Change in High-density Lipoprotein | change in high-density lipoprotein between baseline and 6 month | Baseline and 6 months |
| Change in Glycosylated Haemoglobin | change in glycosylated haemoglobin between baseline and 6 month | Baseline and 6 months |
| Change in Fasting Blood Glucose | change in fasting blood glucose between baseline and 6 month | Baseline and 6 months |
| Change in Insulin | change in Insulin between baseline and 6 month | Baseline and 6 months |
| Change in Homeostatic Model Assessment for Insulin Resistance | change in homeostatic model assessment for insulin resistance between baseline and 6 month | Baseline and 6 months |
| Change in Adiponectin | change in Adiponectin between baseline and 6 month | Baseline and 6 months |
| Change in Body Mass Index | change in body mass index between baseline and 6 month | Baseline and 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
| Secondary | Change in Urinary Isoprostane | change in urinary isoprostane between baseline and 6 month | Posted | Mean | Standard Deviation | ng/ml | Baseline and 6 months |
|
|
|
| Secondary | Change in Malondialdehyde | change in Malondialdehyde between baseline and 6 month | Posted | Mean | Standard Deviation | nM | Baseline and 6 months |
|
|
|
| Secondary | Change in Office Systolic Blood Pressure | change in office systolic blood pressure between baseline and 6 month | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Change in Office Diastolic Blood Pressure | change in office diastolic blood pressure between baseline and 6 month | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure | change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure | change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Change in Low-density Lipoprotein | change in low-density lipoprotein between baseline and 6 month | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
|
|
| Secondary | Change in Triglycerides | change in Triglycerides between baseline and 6 month | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
|
|
| Secondary | Change in High-density Lipoprotein | change in high-density lipoprotein between baseline and 6 month | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
|
|
| Secondary | Change in Glycosylated Haemoglobin | change in glycosylated haemoglobin between baseline and 6 month | Posted | Mean | Standard Deviation | percentage of glycosylated haemoglobin | Baseline and 6 months |
|
|
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| Secondary | Change in Fasting Blood Glucose | change in fasting blood glucose between baseline and 6 month | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
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| Secondary | Change in Insulin | change in Insulin between baseline and 6 month | Posted | Mean | Standard Deviation | IU/ml | Baseline and 6 months |
|
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| Secondary | Change in Homeostatic Model Assessment for Insulin Resistance | change in homeostatic model assessment for insulin resistance between baseline and 6 month | Posted | Mean | Standard Deviation | HOMA units | Baseline and 6 months |
|
|
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| Secondary | Change in Adiponectin | change in Adiponectin between baseline and 6 month | Posted | Mean | Standard Deviation | μg/ml | Baseline and 6 months |
|
|
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| Secondary | Change in Body Mass Index | change in body mass index between baseline and 6 month | Posted | Mean | Standard Deviation | kg/m2 | Baseline and 6 months |
|
|
|
| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Rosiglitazone | simvastatin 40 mg/day plus rosiglitazone 4 mg/day | 0 | 23 | 9 | 23 |
| Nausea Vomiting | Gastrointestinal disorders |
|
| Upper respiratory symptoms | Respiratory, thoracic and mediastinal disorders |
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| Headaches | Nervous system disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Constipation | Gastrointestinal disorders |
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| Joint aches | Musculoskeletal and connective tissue disorders | vague complaints of joint aches involving the knee, hip or ankle in all cases at least 2 or more of these joints |
|
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |