Clinical trial NCT02227784: A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
Official title: The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, 3 Months
measure: Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
timeFrame: Baseline, 3 Months
measure: Percent Change From Baseline to 3 Months in Non-HDL-C
timeFrame: Baseline, 3 Months
measure: Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
timeFrame: Baseline, 3 Months
measure: Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
timeFrame: Baseline, 3 Months
measure: Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
timeFrame: Baseline, 3 Months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Med Clinic LLC
state: Arizona
city: Carmichael
country: United States
facility: Advanced Clinical Research
state: California
city: Encino
country: United States
facility: Tooraj Joseph Raoof M.D., Inc.
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Colorado Springs
country: United States
facility: Cardiac Research
state: Colorado
city: Boynton Beach
country: United States
facility: ZASA Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Cardiology Research Assoc.
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Alan Graff, MD, PA
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute, LLC
state: Florida
city: Covington
country: United States
facility: Georgia Heart Specialists
state: Georgia
city: Gainesville
country: United States
facility: United Osteoporosis Center
state: Georgia
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Heart Clinical Research, LLC
state: Illinois
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest CRC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Heart Physicians Inc
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Louisville
country: United States
facility: Community Medical Associates
state: Kentucky
city: Bossier City
country: United States
facility: Grace Research
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: Baltimore
country: United States
facility: Overlea Personal Physicians
state: Maryland
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Somerset
country: United States
facility: Heart and Vascular Center of New Brunswick LLC
state: New Jersey
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: Saratoga Springs
country: United States
facility: Saratoga Clinical Research LLC
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology and Pulmonary Associates, P.C.
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Internal Medicine, P.A.
state: North Carolina
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice Willis Clinic, PA
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: Portland Preventive Cardiology, LLC
state: Oregon
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research Group
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Richmond
country: United States
facility: National Clinical Research - Richmond
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Kootenai Heart Clinics, LLC
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists Inc
state: Wisconsin
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.