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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02227784
First received: August 26, 2014
Last updated: October 15, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change from Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Percent Change from Baseline to 3 Months in Apolipoprotein AI (apoAI) [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Percent Change from Baseline to 3 Months in Non-HDL-C [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Percent Change from Baseline to 3 Months in Apolipoprotein B (apoB) [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Percent Change from Baseline to 3 Months in Cholesterol Efflux Capacity [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Percent Change from Baseline to 3 Months in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 396
Study Start Date: October 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: November 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
Genders Eligible for Study:   Both
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) ≥8.0%
  • 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

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 56 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02227784     History of Changes
Other Study ID Numbers: 14502, I1V-MC-EIBH
Study First Received: August 26, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014