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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653-153 |
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Poor enrollment
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| Name | Class |
|---|---|
| Merck Frosst Canada Ltd. | INDUSTRY |
| Schering-Plough | INDUSTRY |
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In South Asian Canadians with documented coronary artery disease or diabetes and hypercholesterolemia with LDL-C levels > 2.0 mmol/L after 4 weeks of monotherapy with any statin: To compare the percent (%) of patients who achieve an LDL-C concentration of 2.0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with any statin at any dose versus doubling of the current statin dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZE+statin | Experimental | ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. |
|
| Stat2 | Active Comparator | patients on statins has their dose doubled for 6 weeks followed by another 6 weeks in which ezetimibe is added or the statin dose is doubled again. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe | Drug | ezetimibe 10 mg/day over a 6-week course of treatment. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary measure of efficacy will be the percentage of patients in each treatment arm achieving a target LDL-C > 2.0 mmol/L at week 6 assessment. This will be calculated as the percentage of patients achieving this end point at 6 weeks of treatment us | 6 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Frosst Canada Ltd. | Kirkland | Quebec | H9H 3L1 | Canada |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| 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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| Comparator: Simvastatin 20, 40 and 80 mg |
| Drug |
Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. |
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| Comparator: Atorvastatin | Drug | Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. |
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| Comparator: Rosuvastatin | Drug | Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. |
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| D009750 |
| Nutritional and Metabolic Diseases |