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Trial record 21 of 26 for:    evacetrapib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260648
Recruitment Status : Terminated (Study termination due to insufficient efficacy.)
First Posted : October 9, 2014
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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 with primary hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Evacetrapib Drug: Ezetimibe Drug: Atorvastatin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Efficacy and Safety Study of Evacetrapib in Combination With Atorvastatin in Japanese Patients With Primary Hypercholesterolemia
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Evacetrapib
130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Drug: Atorvastatin
Administered orally

Active Comparator: Ezetimibe
10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
Drug: Ezetimibe
Administered orally

Drug: Atorvastatin
Administered orally

Placebo Comparator: Placebo
Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
Drug: Atorvastatin
Administered orally

Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification [ Time Frame: Baseline, Week 12 ]
    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.


Secondary Outcome Measures :
  1. Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 12 ]
    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.

  2. Percent Change From Baseline to Week 12 in LDL-C (Direct) [ Time Frame: Baseline, Week 12 ]
    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.

  3. Percent Change From Baseline to Week 12 in Non HDL-C [ Time Frame: Baseline, Week 12 ]
    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.

  4. Percent Change From Baseline to Week 12 in Lipoprotein-a [ Time Frame: Baseline, Week 12 ]
    The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

  5. Percent Change From Baseline to Week 12 in Apolipoprotein A-I [ Time Frame: Baseline, Week 12 ]
    The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

  6. Percent Change From Baseline to Week 12 in Apolipoprotein B [ Time Frame: Baseline, Week 12 ]
    The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260648


Locations
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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, 650-0021
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, 311-3516
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
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
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, 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.
Saitama, Japan, 350-1305
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, 424-0855
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, 103-0028
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02260648    
Other Study ID Numbers: 14501
I1V-JE-EIBG ( Other Identifier: Eli Lilly and Company )
First Posted: October 9, 2014    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Evacetrapib
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors