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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-JE-EIBG | Other Identifier | Eli Lilly and Company |
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Study termination due to insufficient efficacy.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib | Experimental | 130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks. |
|
| Ezetimibe | Active Comparator | 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm. |
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| Placebo | Placebo Comparator | Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.)
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
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).
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 650-0021 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evacetrapib | 130 milligram (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks. |
| FG001 | Placebo | Placebo and 10 mg atorvastatin administered orally (PO) once a day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ezetimibe | Drug | Administered orally |
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| Atorvastatin | Drug | Administered orally |
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| Placebo | Drug | Administered orally |
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| Baseline, Week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 311-3516 | 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 | 311-4153 | 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 | 6150035 | 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 | 530-0001 | 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 | 350-1305 | 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 | 424-0855 | 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 | 103-0028 | Japan |
| FG002 | Ezetimibe | 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm. |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Evacetrapib | 130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks. |
| BG001 | Placebo | Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks. |
| BG002 | Ezetimibe | 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in LDL-C | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in HDL-C | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in LDL-C (Direct) | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in non HDL-C | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in Lipoprotein-a | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in Apolipoprotein A-I | Baseline, Week 12 |
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| 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change in Apolipoprotien B | Baseline, Week 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evacetrapib | 130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks. | 0 | 53 | 18 | 53 | ||
| EG001 | Placebo | Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks. | 0 | 46 | 13 | 46 | ||
| EG002 | Ezetimibe | 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm. | 0 | 50 | 12 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Presbyacusis | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Genital herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Tinea infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Urethritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Electrocardiogram qt prolonged | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Mental fatigue | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Erythema ab igne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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The study was terminated prematurely due to insufficient efficacy of the I1V-MC-EIAN (NCT01687998) study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C568301 | evacetrapib |
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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