A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atorvastatin; Atorvastatin Calcium; Evacetrapib; Ezetimibe

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).