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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

Objective

To evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD)

Eli Lilly and Company

Timeline

Timeline
Start Date October 2012
Estimated end Date January 2016
Status Recruiting

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

Study Description

Study Description
Study Type Interventional
Study Phase Phase 3
Study Design
Allocation Randomized
Endpoint Safety/efficacy study
Interventional Model Parallel assignment
Masking Double blind
Study Details
Primary Purpose Treatment
Condition Cardiovascular diseases
Intervention Evacetrapib, another name is LY2484595 (administered orally)
Placebo (administered orally)
Study Arms
  • Evacetrapib: 130 mg tablet administered orally once daily for up to 4 years.
  • Placebo: Placebo tablet administered orally once daily for up to 4 years.
Population Size Estimated patients enrolled: 11000 patients

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of):
  • Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
  • Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])
  • Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
  • Meet 1 of the following criteria:
    • Screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]
    • If LDL-C is greater than target, the patient participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin

Exclusion Criteria

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or :device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
  • Female participants who are known to be pregnant or breastfeeding
  • Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of :birth control during the study
  • History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
  • Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic blood pressure ≥110 mm Hg at screening or randomization
  • History of hemorrhagic stroke or intracranial hemorrhage
  • New York Heart Association class III or IV congestive heart failure
  • Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [μmol/L]) at screening
  • Clinically active liver disease. Participants are not excluded due to Gilbert's Syndrome or a history of cholelithiasis/cholecystectomy
  • History of malignancy within the preceding 3 years prior to screening
  • Known malabsorption syndrome with the exception of lactose intolerance
  • Participants with a known history of primary or secondary hyperaldosteronism
  • Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
  • Any clinically significant medical condition that according to the investigator could interfere with participation in the study
  • Participants whose life expectancy is anticipated to be less than 4 years
  • Unable or unwilling to comply with study requirements, or deemed by the investigator to be unfit for the study
  • Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
  • Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic administration of drugs on the exclusion list
  • Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months
  • Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, participants may be screened and :enrolled after all such planned procedures are completed.

Outcomes

Primary Outcomes

  • Time to First Occurence of the Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or :Hospitalization for Unstable Angina (UA)
    • Time Frame: Baseline to study completion (estimated to be up to 4 years)
    • Designated as safety issue: No

Secondary Outcomes

  • Mean Percent Change from Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) levels
    • Time Frame: Baseline, 3 Months
    • Designated as safety issue: No
  • Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
    • Time Frame: :Baseline through End of Study (estimated up to 4 years)
    • Designated as safety issue: No
  • Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization
    • Time Frame: Baseline through End of Study (estimated up to 4 years)
    • Designated as safety issue: No
  • Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
    • Time Frame: Baseline through End of Study (estimated :up to 4 years)
    • Designated as safety issue: No
  • Time to First Occurrence of Composite Endpoint of CV Death, MI, or Stroke
    • Time Frame: Baseline through End of Study (estimated up to 4 years)
    • Designated :as safety issue: No

Publications

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Pending

Conclusion

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References