Study Stopped
Study termination due to program termination.
A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
ACCENTUATE
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
2 other identifiers
interventional
366
2 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
March 22, 2018
CompletedOctober 8, 2019
September 1, 2019
1.2 years
August 26, 2014
February 18, 2018
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Non-HDL-C
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
Baseline, 3 Months
- +1 more secondary outcomes
Study Arms (4)
Atorvastatin + Evacetrapib
EXPERIMENTALAtorvastatin 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 COMPARATORAtorvastatin 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 COMPARATORAtorvastatin 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 COMPARATORAtorvastatin 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.
Interventions
Administered orally
Administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Desert Clinical Research
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
Related Publications (1)
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.
PMID: 28412650DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination was due to program termination.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2014
First Posted
August 28, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 8, 2019
Results First Posted
March 22, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.