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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)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01824238
Collaborator
(none)
68
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anacetrapib

Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.

Drug: Anacetrapib
Other Names:
  • MK-0859

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo for anacetrapib

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [Baseline and Week 12]

    2. Percentage of Participants who Experience at Least One Adverse Event (AE) [12 weeks]

    Secondary Outcome Measures

    1. Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [Baseline and Week 12]

    2. Percent Change from Baseline in Non-HDL-C [Baseline and Week 12]

    3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [Baseline and Week 12]

    4. Percent Change from Baseline in Apolipoprotein B (Apo-B) [Baseline and Week 12]

    5. Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [Baseline and Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01824238
    Other Study ID Numbers:
    • 0859-050
    • 132234
    First Posted:
    Apr 4, 2013
    Last Update Posted:
    Apr 25, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia
    Oxazolidinones
    Anacetrapib

    Study Results

    No Results Posted as of Apr 25, 2016