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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 Heterozygous Familial Hypercholesterolemia (MK-0859-050)

Primary Purpose

Heterozygous Familial Hypercholesterolemia (HeFH)

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 Heterozygous Familial Hypercholesterolemia (HeFH)

Eligibility Criteria

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

Inclusion Criteria:

  • If female, cannot be of reproductive potential
  • Diagnosed with heterozygous familial hypercholesterolemia
  • Have been treated with an appropriate and

stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks

Exclusion Criteria:

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous 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 tablet, orally, once-daily for 12 weeks.

    Participants will receive placebo tablet, orally, once daily for 12 weeks.

    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 A-I (Apo-A-I)
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Percent Change from Baseline in Lipoprotein(a) (Lp[a])

    Full Information

    First Posted
    April 1, 2013
    Last Updated
    April 22, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01824238
    Brief Title
    A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)
    Official Title
    A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 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 evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heterozygous Familial Hypercholesterolemia (HeFH)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anacetrapib
    Arm Type
    Experimental
    Arm Description
    Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive placebo tablet, orally, once daily for 12 weeks.
    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 12
    Title
    Percentage of Participants who Experience at Least One Adverse Event (AE)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    Time Frame
    Baseline and Week 12
    Title
    Percent Change from Baseline in Non-HDL-C
    Time Frame
    Baseline and Week 12
    Title
    Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    Time Frame
    Baseline and Week 12
    Title
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Time Frame
    Baseline and Week 12
    Title
    Percent Change from Baseline in Lipoprotein(a) (Lp[a])
    Time Frame
    Baseline and Week 12

    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 Diagnosed with heterozygous familial hypercholesterolemia Have been treated with an appropriate and stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks Exclusion Criteria: Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor Homozygous 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
    27131642
    Citation
    Arai H, Teramoto T, Daida H, Ikewaki K, Maeda Y, Nakagomi M, Shirakawa M, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Vaidya S, Blaustein RO. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with heterozygous familial hypercholesterolemia. Atherosclerosis. 2016 Jun;249:215-23. doi: 10.1016/j.atherosclerosis.2016.03.017. Epub 2016 Mar 25.
    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 Heterozygous Familial Hypercholesterolemia (MK-0859-050)

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