Clinical trial NCT02260635: A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
Official title: A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in LDL-C (Direct)
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Non HDL-C
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Lipoprotein-a
timeFrame: Baseline, Week 12, Week 52
measure: Percent Change From Baseline in Apolipoprotein A-I
timeFrame: Baseline, Week 12, Week 52
measure: Percent Change From Baseline in Apolipoprotein B
timeFrame: Baseline, Week 12, Week 52
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: