A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
NCT ID: NCT02227784
Last Updated: 2019-10-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
366 participants
INTERVENTIONAL
2014-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Evacetrapib
Administered orally
Atorvastatin
Administered orally
Placebo
Administered orally
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.
Atorvastatin
Administered orally
Placebo
Administered orally
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
Administered orally
Ezetimibe
Administered orally
Placebo
Administered orally
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.
Atorvastatin
Administered orally
Placebo
Administered orally
Interventions
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Evacetrapib
Administered orally
Atorvastatin
Administered orally
Ezetimibe
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an LDL-C \>70 mg/deciliter(dL) or non-HDL-C \>100 mg/dL
* Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
* Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes
Exclusion Criteria
* New York Heart Association (NYHA) class III or IV congestive heart failure
* History of either a transient ischemic stroke or ischemic stroke \<30 days
* History of acute coronary syndrome (ACS) \<30 days
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Desert Clinical Research
Mesa, Arizona, United States
Central Phoenix Med Clinic LLC
Phoenix, Arizona, United States
Advanced Clinical Research
Carmichael, California, United States
Tooraj Joseph Raoof M.D., Inc.
Encino, California, United States
Irvine Clinical Research Center
Irvine, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Rancho Cucamonga Clinical
Rancho Cucamonga, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Cardiac Research
Colorado Springs, Colorado, United States
ZASA Clinical Research
Boynton Beach, Florida, United States
Cardiology Research Assoc.
Daytona Beach, Florida, United States
Avail Clinical Research LLC
DeLand, Florida, United States
Alan Graff, MD, PA
Fort Lauderdale, Florida, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Cardiology Partners Clinical Research Institute, LLC
Wellington, Florida, United States
Georgia Heart Specialists
Covington, Georgia, United States
United Osteoporosis Center
Gainesville, Georgia, United States
East West Medical Institute
Honolulu, Hawaii, United States
Solaris Clinical Research
Meridian, Idaho, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Midwest CRC
Crystal Lake, Illinois, United States
Indiana Heart Physicians Inc
Indianapolis, Indiana, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Community Medical Associates
Louisville, Kentucky, United States
Grace Research
Bossier City, Louisiana, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States
Overlea Personal Physicians
Baltimore, Maryland, United States
Cape Cod Research Institute
Hyannis, Massachusetts, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
Heart and Vascular Center of New Brunswick LLC
Somerset, New Jersey, United States
Medex Healthcare Research, Inc.
New York, New York, United States
Saratoga Clinical Research LLC
Saratoga Springs, New York, United States
Buffalo Cardiology and Pulmonary Associates, P.C.
Williamsville, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Boice Willis Clinic, PA
Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Aventiv Research
Columbus, Ohio, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Portland Preventive Cardiology, LLC
Portland, Oregon, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, United States
Black Hills Cardiovascular Research Group
Rapid City, South Dakota, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States
Northwest Houston Heart Center
Tomball, Texas, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Kootenai Heart Clinics, LLC
Spokane, Washington, United States
Clinical Investigation Specialists Inc
Kenosha, Wisconsin, United States
Research and Cardiovascular Corp.
Ponce, , Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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I1V-MC-EIBH
Identifier Type: OTHER
Identifier Source: secondary_id
14502
Identifier Type: -
Identifier Source: org_study_id
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