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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653-152 | |||
| 2008_005 |
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To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months. |
|
| Group 2 | Active Comparator | Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe | Drug | ezetimibe 10 mg/day for a six week course of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22291820 | Result | Shekhar Pandey A, Bissonnette S, Boukas S, Rampakakis E, Sampalis JS. Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial. Arch Med Sci. 2011 Oct;7(5):767-75. doi: 10.5114/aoms.2011.25550. Epub 2011 Nov 8. |
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| statins | Drug | patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase |
|
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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