NCT00536510

Effect of MK0524A on Cholesterol Levels (0524A-048)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 646 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.

Conditions

• Hypercholesterolemia
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	laropiprant/niacin (MK0524A)	Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization
DRUG	Comparator: placebo	Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-09-27
• Last updated: 2015-09-02
• Results posted: 2009-05-13