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

This study has been terminated.
(Study termination due to program termination.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02227784
First received: August 26, 2014
Last updated: September 2, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Hyperlipidemia Drug: Evacetrapib Drug: Atorvastatin Drug: Ezetimibe Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Percent Change from Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, 3 Months ]
  • Percent Change from Baseline to 3 Months in Apolipoprotein AI (apoAI) [ Time Frame: Baseline, 3 Months ]
  • Percent Change from Baseline to 3 Months in Non-HDL-C [ Time Frame: Baseline, 3 Months ]
  • Percent Change from Baseline to 3 Months in Apolipoprotein B (apoB) [ Time Frame: Baseline, 3 Months ]
  • Percent Change from Baseline to 3 Months in Cholesterol Efflux Capacity [ Time Frame: Baseline, 3 Months ]
  • Percent Change from Baseline to 3 Months in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline, 3 Months ]

Enrollment: 366
Study Start Date: October 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Lipitor
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
Other Name: Lipitor
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
Other Name: Lipitor
Drug: Ezetimibe
Administered orally
Other Name: Zetia
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
Other Name: Lipitor
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02227784

  Show 64 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

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 )
Study First Received: August 26, 2014
Last Updated: September 2, 2016

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Ezetimibe
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017