drugset / Trial / NCT01274559

Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

NCT01274559

Phase 3 Terminated 1173 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant \[ERN/LRPT (MK-0524A)\] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin, atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.

Timeline

Start
2011-03-01
Primary completion
2013-02-26
Completion
2013-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Niacin Small molecule 2 g Oral
Subject laropiprant Small molecule 40 mg Oral