NCT00977288

A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)

A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

Detailed description

This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients. Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period. As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	anacetrapib	10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
DRUG	Comparator: atorvastatin	atorvastatin tablet, 10mg, once daily for 8 weeks
DRUG	Comparator: Placebo	Placebo tablet, once daily for 8 weeks

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2014-04-01
• First posted: 2009-09-15
• Last updated: 2015-05-06