Status:
TERMINATED
A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02260648
Start Date
January 1 2015
End Date
November 1 2015
Last Update
October 9 2018
Active Locations (8)
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1
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.
Hyōgo, Japan, 650-0021
2
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.
Ibaraki, Japan, 311-3516
3
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.
Ibaraki, Japan, 311-4153
4
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.
Kyoto, Japan, 6150035