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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe + Rosuvastatin | Experimental |
| |
| Ezetimibe | Active Comparator |
| |
| Rosuvastatin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe + Rosuvastatin | Drug | oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in total cholesterol, LDL-C, HDL-C, and triglycerides. | Day 15 | |
| Safety: adverse events, laboratory test results, physical examination, vital signs. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate potential for PK interaction between ezetimibe and rosuvastatin as indicated by Cmax and AUC. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15324521 | Result | Kosoglou T, Statkevich P, Yang B, Suresh R, Zhu Y, Boutros T, Maxwell SE, Tiessen R, Cutler DL. Pharmacodynamic interaction between ezetimibe and rosuvastatin. Curr Med Res Opin. 2004 Aug;20(8):1185-95. doi: 10.1185/030079904125004213. |
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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 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Rosuvastatin | Drug | oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days |
|
|
| Placebo | Drug | oral tablets; two ezetimibe placebo once daily for 14 days |
|
| Ezetimibe | Drug | oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |