A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol (ACCENTUATE)
Hyperlipidemia
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
- 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:
- Have a hemoglobin A1c (HbA1c) >9.5%
- 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
Sites / Locations
- Heart Center Research, LLC
- Desert Clinical Research
- Central Phoenix Med Clinic LLC
- Advanced Clinical Research
- Tooraj Joseph Raoof M.D., Inc.
- Irvine Clinical Research Center
- VA Long Beach Healthcare System
- Rancho Cucamonga Clinical
- Encompass Clinical Research
- University Clinical Investigators, Inc.
- Diablo Clinical Research
- University of Colorado Health Sciences Center
- Cardiac Research
- ZASA Clinical Research
- Cardiology Research Assoc.
- Avail Clinical Research LLC
- Alan Graff, MD, PA
- Nature Coast Clinical Research, LLC
- Suncoast Research Group, LLC
- Progressive Medical Research
- Cardiology Partners Clinical Research Institute, LLC
- Georgia Heart Specialists
- United Osteoporosis Center
- East West Medical Institute
- Solaris Clinical Research
- Northwest Heart Clinical Research, LLC
- Cedar-Crosse Research Center
- Midwest CRC
- Indiana Heart Physicians Inc
- Midwest Institute for Clinical Research
- Hutchinson Clinic
- Community Medical Associates
- Grace Research
- Maryland Cardiovascular Specialists
- Overlea Personal Physicians
- Cape Cod Research Institute
- ActivMed Practices & Research, Inc
- Medex Healthcare Research, Inc.
- Palm Research Center
- Heart and Vascular Center of New Brunswick LLC
- Medex Healthcare Research, Inc.
- Saratoga Clinical Research LLC
- Buffalo Cardiology and Pulmonary Associates, P.C.
- Asheville Cardiology Associates
- Metrolina Internal Medicine, P.A.
- High Point Clinical Trials Center
- Boice Willis Clinic, PA
- PMG Research of Wilmington, LLC
- Lillestol Research LLC
- Aventiv Research
- South Oklahoma Heart Research, LLC
- Portland Preventive Cardiology, LLC
- Partners in Clinical Research
- PMG Research of Charleston, LLC
- Black Hills Cardiovascular Research Group
- Holston Medical Group Clinical Research
- Northwest Houston Heart Center
- National Clinical Research - Richmond
- Northwest Clinical Research Center
- Kootenai Heart Clinics, LLC
- Clinical Investigation Specialists Inc
- Research and Cardiovascular Corp.
- Clinical Research Puerto Rico, Inc.
- GCM Medical Group PSC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Active Comparator
Atorvastatin + Evacetrapib
Atorvastatin 80 mg
Atorvastatin + Ezetimibe
Atorvastatin 40 mg
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 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 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 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.