A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia
NCT ID: NCT02260648
Last Updated: 2018-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
149 participants
INTERVENTIONAL
2015-01-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Evacetrapib
130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
Evacetrapib
Administered orally
Atorvastatin
Administered orally
Ezetimibe
10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
Ezetimibe
Administered orally
Atorvastatin
Administered orally
Placebo
Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
Atorvastatin
Administered orally
Placebo
Administered orally
Interventions
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Evacetrapib
Administered orally
Ezetimibe
Administered orally
Atorvastatin
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
20 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
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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
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
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
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
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.
Saitama, , 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.
Shizuoka, , 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
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Other Identifiers
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I1V-JE-EIBG
Identifier Type: OTHER
Identifier Source: secondary_id
14501
Identifier Type: -
Identifier Source: org_study_id
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