A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol (ACCENTUATE)
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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
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | August 26, 2014 | ||||||||||||||||
First Posted Date ICMJE | August 28, 2014 | ||||||||||||||||
Results First Submitted Date ICMJE | February 18, 2018 | ||||||||||||||||
Results First Posted Date ICMJE | March 22, 2018 | ||||||||||||||||
Last Update Posted Date | October 8, 2019 | ||||||||||||||||
Study Start Date ICMJE | October 2014 | ||||||||||||||||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, 3 Months ] | ||||||||||||||||
Change History | Complete list of historical versions of study NCT02227784 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol | ||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||
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. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hyperlipidemia | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||
Actual Enrollment ICMJE |
366 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
396 | ||||||||||||||||
Actual Study Completion Date ICMJE | December 2015 | ||||||||||||||||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Puerto Rico, United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT02227784 | ||||||||||||||||
Other Study ID Numbers ICMJE | 14502 I1V-MC-EIBH ( Other Identifier: Eli Lilly and Company ) |
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Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Eli Lilly and Company | ||||||||||||||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | ||||||||||||||||
Verification Date | September 2019 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |