Clinical Trials

Summary results of phase 4 studies of niacin compound reported

Published in Medical Letter on the CDC and FDA, March 26th, 2006

Kos Pharmaceuticals, Inc. (KOSP) announced results from two studies that represent milestones in its research and development activities: data from a study with an optimized Niaspan MF dosage strength and data from the COMPELL (comparative effects on lipid levels of niaspan and statins versus other lipid therapies) phase 4 efficacy trial.

This study was a single dose, double-blind, randomized, placebo-controlled three-way crossover, human study (N=156) evaluating a Niaspan (niacin extended-release tablets) modified formulation for reduction in severity and duration of flushing, a relatively common and transient nuisance side effect for patients who take Niaspan to...

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Source: Medical Letter on the CDC and FDA (2006-03-26)

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