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

Hypercholesterolemia Clinical Trial

Official title:

A Double-Blind Efficacy and Safety Study of Evacetrapib in Combination With Atorvastatin in Japanese Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02260648
• Other study ID #: 14501
• Secondary ID: I1V-JE-EIBG
• Status: Terminated
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with primary hypercholesterolemia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 149
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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).

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Evacetrapib
Administered orally
• Ezetimibe
Administered orally
• Atorvastatin
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
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.	Hyogo
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.	Ibaragi
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification	The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)	The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in LDL-C (Direct)	The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in Non HDL-C	The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in Lipoprotein-a	The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in Apolipoprotein A-I	The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.	Baseline, Week 12
Secondary	Percent Change From Baseline to Week 12 in Apolipoprotein B	The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.	Baseline, Week 12