- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260635
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
February 18, 2018 updated by: Eli Lilly and Company
A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan, 530-0001
- 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.
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Tokyo, Japan, 103-0028
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Administered orally
Other Names:
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Placebo Comparator: 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.
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Administered orally
Administered orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
Time Frame: Baseline, Week 12
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Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline, Week 12
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LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
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Baseline, Week 12
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Percent Change From Baseline in LDL-C (Direct)
Time Frame: Baseline, Week 12
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LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
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Baseline, Week 12
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Percent Change From Baseline in Non HDL-C
Time Frame: Baseline, Week 12
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LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
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Baseline, Week 12
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Percent Change From Baseline in Lipoprotein-a
Time Frame: Baseline, Week 12, Week 52
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LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
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Baseline, Week 12, Week 52
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Percent Change From Baseline in Apolipoprotein A-I
Time Frame: Baseline, Week 12, Week 52
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LS Mean from ANCOVA model adjusted for baseline and treatment.
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Baseline, Week 12, Week 52
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Percent Change From Baseline in Apolipoprotein B
Time Frame: Baseline, Week 12, Week 52
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LS Mean from ANCOVA model adjusted for baseline and treatment.
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Baseline, Week 12, Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 6, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 9, 2014
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
February 18, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14503
- I1V-JE-EIBI (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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