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| ID | Type | Description | Link |
|---|---|---|---|
| MK0524A-023 | |||
| 2006_504 |
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This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo → MK-0524A 2g | Placebo Comparator | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days). |
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| Placebo → Extended Release (ER)-Niacin 2g | Active Comparator | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days) |
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| MK-0524A 2g | Experimental | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0524A | Drug |
| ||
| ER Niacin |
| Measure | Description | Time Frame |
|---|---|---|
| Global Flushing Severity Score (GFSS) during 7 days of treatment | during 7 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Adverse Event | up to 10 weeks | |
| Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event | up to 10 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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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug |
|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |