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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653-050 | |||
| 2007_559 |
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ezetimibe 10 mg tablet plus simvastatin 20 mg tablet |
|
| 2 | Active Comparator | ezetimibe 10 mg tablet |
|
| 3 | Active Comparator | simvastatin 20 mg tablet |
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| 4 | Placebo Comparator | matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe | Drug | ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. | Based on 7 week treatment periods. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. | Based on 7 week treatment periods. |
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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 |
|---|---|---|---|
| 19380898 | Result | Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20. |
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| Comparator: Placebo (unspecified) | Drug | matching placebo tablet. Duration of Treatment 31 Weeks. |
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| simvastatin | Drug | simvastatin 20 mg tablet. Duration of Treatment 31 Weeks. |
|
|
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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