Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIBH | Other Identifier | Eli Lilly and Company |
Not provided
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Study termination due to program termination.
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The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin + Evacetrapib | Experimental | Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
| Atorvastatin 80 mg | Active Comparator | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
| Atorvastatin + Ezetimibe | Active Comparator | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
| Atorvastatin 40 mg | Active Comparator | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) | Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | Baseline, 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) | Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Desert Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28412650 | Derived | Nicholls SJ, Ray KK, Ballantyne CM, Beacham LA, Miller DL, Ruotolo G, Nissen SE, Riesmeyer JS; ACCENTUATE Investigators. Comparative effects of cholesteryl ester transfer protein inhibition, statin or ezetimibe on lipid factors: The ACCENTUATE trial. Atherosclerosis. 2017 Jun;261:12-18. doi: 10.1016/j.atherosclerosis.2017.04.008. Epub 2017 Apr 8. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin + Evacetrapib | Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Atorvastatin | Drug | Administered orally |
|
| Ezetimibe | Drug | Administered orally |
|
| Placebo | Drug | Administered orally |
|
| Baseline, 3 Months |
| Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI) | Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | Baseline, 3 Months |
| Percent Change From Baseline to 3 Months in Non-HDL-C | Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure. | Baseline, 3 Months |
| Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB) | Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | Baseline, 3 Months |
| Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity | Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | Baseline, 3 Months |
| Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a]) | Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | Baseline, 3 Months |
| Mesa |
| Arizona |
| 85213 |
| United States |
| Central Phoenix Med Clinic LLC | Phoenix | Arizona | 85020 | United States |
| Advanced Clinical Research | Carmichael | California | 95608 | United States |
| Tooraj Joseph Raoof M.D., Inc. | Encino | California | 91436 | United States |
| Irvine Clinical Research Center | Irvine | California | 92618 | United States |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Rancho Cucamonga Clinical | Rancho Cucamonga | California | 91730 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045-2517 | United States |
| Cardiac Research | Colorado Springs | Colorado | 80909 | United States |
| ZASA Clinical Research | Boynton Beach | Florida | 33472 | United States |
| Cardiology Research Assoc. | Daytona Beach | Florida | 32117 | United States |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | United States |
| Alan Graff, MD, PA | Fort Lauderdale | Florida | 33308 | United States |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Cardiology Partners Clinical Research Institute, LLC | Wellington | Florida | 33449 | United States |
| Georgia Heart Specialists | Covington | Georgia | 30014 | United States |
| United Osteoporosis Center | Gainesville | Georgia | 30501 | United States |
| East West Medical Institute | Honolulu | Hawaii | 96814 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois | 60005 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Midwest CRC | Crystal Lake | Illinois | 60012 | United States |
| Indiana Heart Physicians Inc | Indianapolis | Indiana | 46237 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| Hutchinson Clinic | Hutchinson | Kansas | 67502 | United States |
| Community Medical Associates | Louisville | Kentucky | 40205 | United States |
| Grace Research | Bossier City | Louisiana | 71111 | United States |
| Maryland Cardiovascular Specialists | Baltimore | Maryland | 21229 | United States |
| Overlea Personal Physicians | Baltimore | Maryland | 21236 | United States |
| Cape Cod Research Institute | Hyannis | Massachusetts | 02601 | United States |
| ActivMed Practices & Research, Inc | Methuen | Massachusetts | 01844 | United States |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | United States |
| Palm Research Center | Las Vegas | Nevada | 89128 | United States |
| Heart and Vascular Center of New Brunswick LLC | Somerset | New Jersey | 08873 | United States |
| Medex Healthcare Research, Inc. | New York | New York | 10036 | United States |
| Saratoga Clinical Research LLC | Saratoga Springs | New York | 12866 | United States |
| Buffalo Cardiology and Pulmonary Associates, P.C. | Williamsville | New York | 14221 | United States |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | United States |
| Metrolina Internal Medicine, P.A. | Charlotte | North Carolina | 28204 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| Boice Willis Clinic, PA | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58103 | United States |
| Aventiv Research | Columbus | Ohio | 43213 | United States |
| South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | 73135 | United States |
| Portland Preventive Cardiology, LLC | Portland | Oregon | 97225 | United States |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | United States |
| PMG Research of Charleston, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Black Hills Cardiovascular Research Group | Rapid City | South Dakota | 57701 | United States |
| Holston Medical Group Clinical Research | Kingsport | Tennessee | 37660 | United States |
| Northwest Houston Heart Center | Tomball | Texas | 77375-4536 | United States |
| National Clinical Research - Richmond | Richmond | Virginia | 23294 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| Kootenai Heart Clinics, LLC | Spokane | Washington | 99204 | United States |
| Clinical Investigation Specialists Inc | Kenosha | Wisconsin | 53142 | United States |
| Research and Cardiovascular Corp. | Ponce | 00717-1322 | Puerto Rico |
| Clinical Research Puerto Rico, Inc. | San Juan | 00909 | Puerto Rico |
| GCM Medical Group PSC | San Juan | 00909 | Puerto Rico |
| Atorvastatin 40 mg |
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| FG002 | Atorvastatin 80 mg | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| FG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| FG004 | Atorvastatin + Evacetrapib Open-Label (OLE) | Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Phase (OLE) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin + Evacetrapib | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| BG001 | Atorvastatin 40 mg | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| BG002 | Atorvastatin 80 mg | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| BG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) | Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | All randomized participants who had evaluable LDL-C data | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) | Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure. | All randomized participants who had evaluable HDL-C data. | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI) | Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | All randomized participants with evaluable apoAI data. | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in Non-HDL-C | Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure. | All randomized participants who had evaluable non-HDL-C data. | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB) | Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | All randomized participants who had evaluable apoB data. | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity | Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | All randomized participants who had evaluable cholesterol efflux capacity | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a]) | Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable. | All randomized participants who had evaluable Lp(a) data. | Posted | Median | 95% Confidence Interval | percent | Baseline, 3 Months |
|
Not provided
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin + Evacetrapib Double-Blind (DB) | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. | 2 | 123 | 6 | 123 | ||
| EG001 | Atorvastatin 40 mg DB | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. | 3 | 54 | 5 | 54 | ||
| EG002 | Atorvastatin 80 mg DB | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. | 3 | 62 | 4 | 62 | ||
| EG003 | Atorvastatin + Ezetimibe DB | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. | 3 | 127 | 5 | 127 | ||
| EG004 | Atorvastatin + Evacetrapib Open-Label (OLE) | Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. | 11 | 247 | 9 | 247 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Benign neoplasm of spinal cord | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
Early termination was due to program termination.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C568301 | evacetrapib |
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |
Not provided
Not provided
| Death |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Median Difference (Final Values) |
| -27.24 |
| 2-Sided |
| 95 |
| -36.6 |
| -18.5 |
| Superiority or Other (legacy) |
| ANCOVA | 0.045 | Median Difference (Final Values) | -6.14 | 2-Sided | 95 | -12.2 | -0.22 | Superiority or Other (legacy) |
| OG002 |
| Atorvastatin 80 mg |
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| OG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
|
|
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
| OG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
|
|
| OG002 |
| Atorvastatin 80 mg |
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| OG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
|
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Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
| OG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
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Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
| OG003 | Atorvastatin 80 mg | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
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Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
| OG003 | Atorvastatin + Ezetimibe | Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. |
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