Conditions: Mixed Hyperlipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2340
Healthy volunteers: no

Brief summary:
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

Detailed description:

Arms:
arm 1: Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks arm 2: Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks arm 3: Atorvastatin 10 mg, orally, once daily for 12 weeks arm 4: Atorvastatin 20 mg, orally, once daily for 12 weeks arm 5: Atorvastatin 40 mg, orally, once daily for 12 weeks arm 6: Atorvastatin 80 mg, orally, once daily for 12 weeks

Interventions: intervention 1: MK-0524A intervention 2: Atorvastatin intervention 3: Simvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: