Conditions: Primary Hypercholesterolemia Mixed Dyslipidemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 2414
Healthy volunteers: no

Brief summary:
This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.

Detailed description:

Arms:
arm 1: After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. arm 2: After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks. arm 3: After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks. arm 4: After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.

Interventions: intervention 1: Comparator: simvastatin intervention 2: MK-0524A intervention 3: Placebo intervention 4: MK-0524B
Intervention descriptions: intervention 1: None intervention 2: Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet intervention 3: None intervention 4: None

Protocol document: