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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
anacetrapib
Comparator: atorvastatin
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    6

    7

    8

    9

    10

    Arm Description

    MK0859 10 mg + placebo

    MK0859 40 mg + placebo

    MK0859 100 mg + placebo

    MK0859 300 mg + placebo

    MK0859 10 mg + atorvastatin 10mg

    MK0859 40 mg + atorvastatin 10mg

    MK0859 100 mg + atorvastatin 10mg

    MK0859 300 mg + atorvastatin 10mg

    Placebo + atorvastatin 10mg

    Placebo

    Outcomes

    Primary Outcome Measures

    The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8

    Secondary Outcome 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

    Full Information

    First Posted
    September 14, 2009
    Last Updated
    May 5, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00977288
    Brief Title
    A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    408 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0859 10 mg + placebo
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    MK0859 40 mg + placebo
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    MK0859 100 mg + placebo
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    MK0859 300 mg + placebo
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    MK0859 10 mg + atorvastatin 10mg
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    MK0859 40 mg + atorvastatin 10mg
    Arm Title
    7
    Arm Type
    Experimental
    Arm Description
    MK0859 100 mg + atorvastatin 10mg
    Arm Title
    8
    Arm Type
    Experimental
    Arm Description
    MK0859 300 mg + atorvastatin 10mg
    Arm Title
    9
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo + atorvastatin 10mg
    Arm Title
    10
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    anacetrapib
    Other Intervention Name(s)
    MK0859
    Intervention Description
    10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin
    Intervention Description
    atorvastatin tablet, 10mg, once daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo tablet, once daily for 8 weeks
    Primary Outcome Measure Information:
    Title
    The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23958252
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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