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

NCT ID: NCT02260635

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Evacetrapib

130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally

Placebo

Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.

Group Type: PLACEBO_COMPARATOR

Evacetrapib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Interventions

Evacetrapib

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY2484595

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Osaka, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, , Japan

Countries

Japan

Other Identifiers

I1V-JE-EIBI

Identifier Type: OTHER

Identifier Source: secondary_id

14503

Identifier Type: -

Identifier Source: org_study_id