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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2010

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 1
    • MK0859 10 mg + placebo
  • Experimental: 2
    • MK0859 40 mg + placebo
  • Experimental: 3
    • MK0859 100 mg + placebo
  • Experimental: 4
    • MK0859 300 mg + placebo
  • Experimental: 5
    • MK0859 10 mg + atorvastatin 10mg
  • Experimental: 6
    • MK0859 40 mg + atorvastatin 10mg
  • Experimental: 7
    • MK0859 100 mg + atorvastatin 10mg
  • Experimental: 8
    • MK0859 300 mg + atorvastatin 10mg
  • Placebo Comparator: 9
    • Placebo + atorvastatin 10mg
  • Placebo Comparator: 10
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
    • Time Frame: 8 weeks

Secondary Measures

  • The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8
    • Time Frame: 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion Criteria

  • Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
  • Patients has uncontrolled diabetes
  • Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5.

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