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A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol (ACCENTUATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227784
Recruitment Status : Terminated (Study termination due to program termination.)
First Posted : August 28, 2014
Results First Posted : March 22, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Evacetrapib Drug: Atorvastatin Drug: Ezetimibe Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: 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.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Drug: Atorvastatin
Administered orally

Drug: Placebo
Administered orally

Active Comparator: 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.
Drug: Atorvastatin
Administered orally

Drug: Placebo
Administered orally

Active Comparator: 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.
Drug: Atorvastatin
Administered orally

Drug: Ezetimibe
Administered orally

Drug: Placebo
Administered orally

Active Comparator: 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.
Drug: Atorvastatin
Administered orally

Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, 3 Months ]
    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.


Secondary Outcome Measures :
  1. Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, 3 Months ]
    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.

  2. Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI) [ Time Frame: Baseline, 3 Months ]
    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.

  3. Percent Change From Baseline to 3 Months in Non-HDL-C [ Time Frame: Baseline, 3 Months ]
    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.

  4. Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB) [ Time Frame: Baseline, 3 Months ]
    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.

  5. Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity [ Time Frame: Baseline, 3 Months ]
    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.

  6. Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline, 3 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227784


  Hide Study Locations
Locations
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United States, Alabama
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
United States, Arizona
Desert Clinical Research
Mesa, Arizona, United States, 85213
Central Phoenix Med Clinic LLC
Phoenix, Arizona, United States, 85020
United States, California
Advanced Clinical Research
Carmichael, California, United States, 95608
Tooraj Joseph Raoof M.D., Inc.
Encino, California, United States, 91436
Irvine Clinical Research Center
Irvine, California, United States, 92618
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Rancho Cucamonga Clinical
Rancho Cucamonga, California, United States, 91730
Encompass Clinical Research
Spring Valley, California, United States, 91978
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045-2517
Cardiac Research
Colorado Springs, Colorado, United States, 80909
United States, Florida
ZASA Clinical Research
Boynton Beach, Florida, United States, 33472
Cardiology Research Assoc.
Daytona Beach, Florida, United States, 32117
Avail Clinical Research LLC
DeLand, Florida, United States, 32720
Alan Graff, MD, PA
Fort Lauderdale, Florida, United States, 33308
Nature Coast Clinical Research, LLC
Inverness, Florida, United States, 34452
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
Progressive Medical Research
Port Orange, Florida, United States, 32127
Cardiology Partners Clinical Research Institute, LLC
Wellington, Florida, United States, 33449
United States, Georgia
Georgia Heart Specialists
Covington, Georgia, United States, 30014
United Osteoporosis Center
Gainesville, Georgia, United States, 30501
United States, Hawaii
East West Medical Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Illinois
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States, 60005
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
Midwest CRC
Crystal Lake, Illinois, United States, 60012
United States, Indiana
Indiana Heart Physicians Inc
Indianapolis, Indiana, United States, 46237
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
United States, Kentucky
Community Medical Associates
Louisville, Kentucky, United States, 40205
United States, Louisiana
Grace Research
Bossier City, Louisiana, United States, 71111
United States, Maryland
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States, 21229
Overlea Personal Physicians
Baltimore, Maryland, United States, 21236
United States, Massachusetts
Cape Cod Research Institute
Hyannis, Massachusetts, United States, 02601
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States, 01844
United States, Missouri
Medex Healthcare Research, Inc.
Saint Louis, Missouri, United States, 63117
United States, Nevada
Palm Research Center
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Heart and Vascular Center of New Brunswick LLC
Somerset, New Jersey, United States, 08873
United States, New York
Medex Healthcare Research, Inc.
New York, New York, United States, 10036
Saratoga Clinical Research LLC
Saratoga Springs, New York, United States, 12866
Buffalo Cardiology and Pulmonary Associates, P.C.
Williamsville, New York, United States, 14221
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, United States, 28204
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
Boice Willis Clinic, PA
Rocky Mount, North Carolina, United States, 27804
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Lillestol Research LLC
Fargo, North Dakota, United States, 58103
United States, Ohio
Aventiv Research
Columbus, Ohio, United States, 43213
United States, Oklahoma
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States, 73135
United States, Oregon
Portland Preventive Cardiology, LLC
Portland, Oregon, United States, 97225
United States, Rhode Island
Partners in Clinical Research
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
PMG Research of Charleston, LLC
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Black Hills Cardiovascular Research Group
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States, 37660
United States, Texas
Northwest Houston Heart Center
Tomball, Texas, United States, 77375-4536
United States, Virginia
National Clinical Research - Richmond
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007-4209
Kootenai Heart Clinics, LLC
Spokane, Washington, United States, 99204
United States, Wisconsin
Clinical Investigation Specialists Inc
Kenosha, Wisconsin, United States, 53142
Puerto Rico
Research and Cardiovascular Corp.
Ponce, Puerto Rico, 00717-1322
Clinical Research Puerto Rico, Inc.
San Juan, Puerto Rico, 00909
GCM Medical Group PSC
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02227784     History of Changes
Other Study ID Numbers: 14502
I1V-MC-EIBH ( Other Identifier: Eli Lilly and Company )
First Posted: August 28, 2014    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors