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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to end of treatment in LDL-C. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines. | 6 weeks | |
| Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily) |
|
| Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations. | Throughout study |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |