Conditions: Primary Hypercholesterolemia Dyslipidemia
Keywords: Low-density lipoprotein LDL High-density lipoprotein HDL Niacin Lipid modifying therapy Cholesterol High cholesterol Triglycerides Mixed Dyslipidemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 977
Healthy volunteers: no

Brief summary:
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).

Detailed description:

Arms:
arm 1: After a 2-week placebo run-in, participants received extended release (ER) niacin/laropiprant (N/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. arm 2: After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.

Interventions: intervention 1: Simvastatin intervention 2: Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM) intervention 3: Extended Release (ER) niacin/laropiprant (N/LRPT) intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: