A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evacetrapib; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind
      treatment period will last for 12 weeks and the open-label extension period will last for an
      additional 40 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C
             levels (measured by a direct method at baseline) that meet the following criteria.
             (Participant categories are based on the definition in Japan Atherosclerosis Society
             2012 guidelines.)

               -  Category I: 160 mg/deciliter (dL)≤LDL-C<200 mg/dL

               -  Category II: 140 mg/dL≤LDL-C<175 mg/dL

               -  Category III: 120 mg/dL≤LDL-C<150 mg/dL

          -  Have triglycerides (TG) ≤400 mg/dL.

          -  Have HDL-C <100 mg/dL.

        Exclusion Criteria:

          -  Participants on LDL apheresis or plasma apheresis.

          -  Participants with secondary hypercholesterolemia or familial hypercholesterolemia.

          -  Any planned angiography. If angiography is planned, participants may be screened and
             enrolled after all such planned procedures are completed.

          -  History of any of the following any conditions:

               -  Stable angina or acute coronary syndrome (unstable angina, myocardial
                  infarction), old myocardial infarction or a coronary revascularization procedure
                  including stent placement, or symptomatic carotid artery disease

               -  peripheral arterial disease

               -  ischemic stroke or transient ischemic attack (TIA)

               -  intracranial hemorrhage

               -  abdominal aortic aneurysm

          -  Have systolic blood pressure (SBP) >160 millimeters of mercury (mm Hg) or diastolic
             blood pressure (DBP) >100 mm Hg.

          -  Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).

          -  During the study period, participants who plan to use, are likely to require, or
             unwilling or unable to stop with adequate washout any prescription, over the counter
             medication, supplements or health foods with the intent to treat serum lipids (LDL-C,
             HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe,
             bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
             Participants taking probucol, fibrate or nicotinic agents within 8 weeks before
             screening are excluded from the study.

          -  Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib
             or dalcetrapib).