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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,139
ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily
ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet taken once daily
Simvastatin 10 mg oral tablet taken once daily
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
Placebo for simvastatin 10 mg oral tablet taken once daily
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels
Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.
Time frame: Baseline and Week 12 and Week 20
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels
Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.
Time frame: Baseline and Week 12 and Week 20
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