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A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anacetrapib
Placebo for anacetrapib
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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • If female, cannot be of reproductive potential
  • Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion Criteria:

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous and heterozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Anacetrapib

    Placebo

    Arm Description

    Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension.

    Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension.

    Outcomes

    Primary Outcome Measures

    Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
    Percentage of Participants who Experience at Least One Adverse Event (AE)

    Secondary Outcome Measures

    Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    Percent Change from Baseline in Non-HDL-C
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    Percent Change from Baseline in Lipoprotein(a) (Lp[a])

    Full Information

    First Posted
    January 2, 2013
    Last Updated
    May 31, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01760460
    Brief Title
    A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)
    Official Title
    A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 14, 2013 (Actual)
    Primary Completion Date
    March 4, 2015 (Actual)
    Study Completion Date
    March 4, 2015 (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 evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with dyslipidemia when added to an existing statin-modifying therapy.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    307 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anacetrapib
    Arm Type
    Experimental
    Arm Description
    Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension.
    Intervention Type
    Drug
    Intervention Name(s)
    Anacetrapib
    Other Intervention Name(s)
    MK-0859
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for anacetrapib
    Primary Outcome Measure Information:
    Title
    Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants who Experience at Least One Adverse Event (AE)
    Time Frame
    64 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Non-HDL-C
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Lipoprotein(a) (Lp[a])
    Time Frame
    Baseline and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: If female, cannot be of reproductive potential Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines Exclusion Criteria: Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor Homozygous and heterozygous familial hypercholesterolemia Severe chronic heart failure Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28478132
    Citation
    Teramoto T, Daida H, Ikewaki K, Arai H, Maeda Y, Nakagomi M, Shirakawa M, Watanabe Y, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Blaustein RO. Lipid-modifying efficacy and tolerability of anacetrapib added to ongoing statin therapy in Japanese patients with dyslipidemia. Atherosclerosis. 2017 Jun;261:69-77. doi: 10.1016/j.atherosclerosis.2017.03.009. Epub 2017 Mar 10.
    Results Reference
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    A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

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