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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
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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 once daily for 6 weeks (plus continued simvastatin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieve target LDL-C as defined by the ESC or NCEP guidelines with ezetimibe added to simvastatin versus continued simvastatin alone | 6 weeks | |
| Percent change from baseline in total cholesterol, HDL-C and triglycerides with ezetimibe added to simvastatin versus continued simvastatin alone. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18545068 | Result | Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D006937 | Hypercholesterolemia |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular 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 tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin) |
|
| 6 weeks |
| D006949 |
| Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |