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

Hyperlipidemia Clinical Trial

— ACCENTUATE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02227784
• Other study ID #: 14502
• Secondary ID: I1V-MC-EIBH
• Status: Terminated
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 366
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Evacetrapib
Administered orally
• Atorvastatin
Administered orally
• Ezetimibe
Administered orally
• Placebo
Administered orally

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)	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.	Baseline, 3 Months
Secondary	Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)	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.	Baseline, 3 Months
Secondary	Percent Change From Baseline to 3 Months in Non-HDL-C	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.	Baseline, 3 Months
Secondary	Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)	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.	Baseline, 3 Months
Secondary	Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity	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.	Baseline, 3 Months
Secondary	Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])	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.	Baseline, 3 Months