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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_662 |
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This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.
Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.
As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0859 10 mg + placebo |
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| 2 | Experimental | MK0859 40 mg + placebo |
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| 3 | Experimental | MK0859 100 mg + placebo |
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| 4 | Experimental | MK0859 300 mg + placebo |
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| 5 | Experimental | MK0859 10 mg + atorvastatin 10mg |
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| 6 | Experimental | MK0859 40 mg + atorvastatin 10mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anacetrapib | Drug | 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8 | 8 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 |
|---|---|---|---|
| 23958252 | Result | Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C530884 | anacetrapib |
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| 7 | Experimental | MK0859 100 mg + atorvastatin 10mg |
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| 8 | Experimental | MK0859 300 mg + atorvastatin 10mg |
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| 9 | Placebo Comparator | Placebo + atorvastatin 10mg |
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| 10 | Placebo Comparator | Placebo |
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| Comparator: atorvastatin | Drug | atorvastatin tablet, 10mg, once daily for 8 weeks |
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| Comparator: Placebo | Drug | Placebo tablet, once daily for 8 weeks |
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