A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evacetrapib; Ezetimibe; Atorvastatin; Placebo
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Atorvastatin; Ezetimibe; Evacetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
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 when administered in combination with atorvastatin for 12 weeks in Japanese
      participants with primary hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be treated with atorvastatin 10 mg/day for at least 30 days prior to study
             initiation.

          -  Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C
             levels (measured by a direct method) 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

               -  Category II: 140 mg/dL≤LDL-C

               -  Category III: 120 mg/dL≤LDL-C

               -  Secondary prevention: 100 mg/dL≤LDL-C

          -  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 homozygous 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 conditions < 90 days prior to study initiation

               -  acute coronary syndrome (unstable angina, acute myocardial infarction)

               -  symptomatic peripheral arterial disease

               -  invasive treatment of carotid artery disease

               -  ischemic stroke or transient ischemic attack (TIA)

               -  intracranial hemorrhage

          -  History of abdominal aortic aneurysm.

          -  Participants with a history of intolerance/hypersensitivity to ezetimibe or statins.

          -  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
             (OTC) 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 (except
             for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA)
             and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic
             agents within 8 weeks before study initiation are excluded from the study.

          -  Have been exposed to cholesteryl ester transfer protein (CETP) inhibitors (for
             example, anacetrapib or dalcetrapib).