NCT00961636

A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of ERN/LRPT in Patients With Dyslipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,152 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	ER niacin (+) laropiprant (ERN/LRPT)	One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
DRUG	ER niacin (+) laropiprant (ERN/LRPT)	One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.
DRUG	Extended-release niacin (ERN)	Two 1g tablets ERN (2g total) once daily for 12 weeks.
DRUG	Placebo to ERN/LRPT	One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-08-19
• Last updated: 2015-02-16
• Results posted: 2012-02-17