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| ID | Type | Description | Link |
|---|---|---|---|
| MK0524B-022 | |||
| 2005_098 |
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This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin (+) laropiprant (+) simvastatin | Drug | Duration of Treatment 12 Weeks |
| |
| Comparator: niacin (+) laropiprant | Drug | Duration of Treatment 12 Weeks |
| |
| Comparator: simvastatin | Drug | Duration of Treatment 12 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A. |
| Measure | Description | Time Frame |
|---|---|---|
| Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin. | ||
| Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A. |
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Inclusion 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 |
|---|---|---|---|
| 24855368 | Derived | Farnier M, Chen E, Johnson-Levonas AO, McCrary Sisk C, Mitchel YB. Effects of extended-release niacin/laropiprant, simvastatin, and the combination on correlations between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients with dyslipidemia. Vasc Health Risk Manag. 2014 May 7;10:279-90. doi: 10.2147/VHRM.S58694. eCollection 2014. | |
| 22658147 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis Link | View IPD |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| C518174 | MK-0524 |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Ballantyne C, Gleim G, Liu N, Sisk CM, Johnson-Levonas AO, Mitchel Y. Effects of coadministered extended-release niacin/laropiprant and simvastatin on lipoprotein subclasses in patients with dyslipidemia. J Clin Lipidol. 2012 May-Jun;6(3):235-43. doi: 10.1016/j.jacl.2011.11.004. Epub 2011 Dec 3. |
| 22500948 | Derived | Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000. |
| 21401833 | Derived | Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x. |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |