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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe + Simvastatin | Experimental |
| |
| Simvastatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe + Simvastatin | Drug | oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C from baseline to endpoint. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. | 6 weeks | |
| Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16893434 | Result | Patel JV, Hughes EA. Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. Int J Clin Pract. 2006 Aug;60(8):914-21. doi: 10.1111/j.1742-1241.2006.01023.x. |
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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 |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Simvastatin | Drug | oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks |
|
|
| Safety: adverse events, laboratory test results, vital signs. | Throughout study |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |