Conditions: Primary Hypercholesterolemia Mixed Dyslipidemia
Keywords: Low-density lipoprotein LDL High-density lipoprotein HDL Niacin Lipid modifying therapy Cholesterol High cholesterol Triglycerides
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 1139
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 /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density lipoprotein cholestrol (LDL-C).

Detailed description:

Arms:
arm 1: Weeks 0-4 (Period 1): Participants will take ERN/LRPT/SIM 1 g/10 mg and SIM-matching placebo tablets daily; Weeks 5-12 (Period 2): Participants will be advanced to ERN/LRPT/SIM 2 g/20 mg and SIM-matching placebo tablets daily; Weeks 13-20 (Period III): Participants will crossover to ERN/LRPT 2 g + SIM 20 mg coadministration treatment. arm 2: Weeks 0-4 (Period I): Participants will take ERN/LRPT co-administered with SIM (ERN/LRPT 1g + SIM 10 mg tablets) daily; Weeks 5-12 (Period II): Participants will be advanced to ERN/LRPT 2 g + SIM 20 mg daily; Weeks 13-20 (Period III): Participants will crossover to the ERN/LRPT/SIM 2 g/20 mg combination treatment and SIM-matching placebo tablets.

Interventions: intervention 1: ER niacin/laropiprant (ERN/LRPT) intervention 2: ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM) intervention 3: Simvastatin (SIM) intervention 4: Placebo Run-In intervention 5: SIM-matching placebo
Intervention descriptions: intervention 1: ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily intervention 2: ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet taken once daily intervention 3: Simvastatin 10 mg oral tablet taken once daily intervention 4: Placebo matches both ER niacin 1 g/laropiprant 20 mg oral tablet and ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet; placebo is taken once daily intervention 5: Placebo for simvastatin 10 mg oral tablet taken once daily

Protocol document: