A Study of Evacetrapib in High-Risk Vascular Disease (ACCELERATE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01687998
First received: September 12, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).


Condition Intervention Phase
Cardiovascular Diseases
Drug: Evacetrapib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 12000
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evacetrapib
Evacetrapib 130 mg tablet, administered orally once , daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
Drug: Evacetrapib
Administered Orally
Other Name: LY2484595
Placebo Comparator: Placebo
Placebo, tablet administered orally once, daily for up to 4 years. Participants will also receive standard of care for HRVD.
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:

  • Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
  • 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]), OR
    • 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:

  • Are 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.
  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: NCT01687998

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35233
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Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36608
United States, Arizona
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Cottonwood, Arizona, United States, 86326
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Glendale, Arizona, United States, 85306
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Tucson, Arizona, United States, 85724
United States, Arkansas
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Fort Smith, Arkansas, United States, 72901
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Little Rock, Arkansas, United States, 72205
United States, California
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Escondido, California, United States, 92029
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Fresno, California, United States, 93710
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Lomita, California, United States, 90717
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Long Beach, California, United States, 90822
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Mission Viejo, California, United States, 92691
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Santa Rosa, California, United States, 95405
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Stockton, California, United States, 95204
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Thousand Oaks, California, United States, 91360
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Torrance, California, United States, 90509
United States, Colorado
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Colorado Springs, Colorado, United States, 80909
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Golden, Colorado, United States, 80401
United States, Connecticut
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Bridgeport, Connecticut, United States, 06606
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Aventura, Florida, United States, 33180
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Boynton Beach, Florida, United States, 33472
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Brandon, Florida, United States, 33511
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Clearwater, Florida, United States, 33756
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Fleming Island, Florida, United States, 32003
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Gainesville, Florida, United States, 32605
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Inverness, Florida, United States, 34452
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Jacksonville, Florida, United States, 32258
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Jupiter, Florida, United States, 33458
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Lakeland, Florida, United States, 33805
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Largo, Florida, United States, 33777
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Margate, Florida, United States, 33063
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33135
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Miami Beach, Florida, United States, 33140
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Naples, Florida, United States, 34102
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32803
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Panama City, Florida, United States, 32401
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Pembroke Pines, Florida, United States, 33026
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Pensacola, Florida, United States, 32501
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Ponte Vedra, Florida, United States, 32081
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Port Charlotte, Florida, United States, 33952
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Safety Harbor, Florida, United States, 34695
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Tallahassee, Florida, United States, 32308
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Wellington, Florida, United States, 33449
United States, Georgia
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Covington, Georgia, United States, 30014
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Cumming, Georgia, United States, 30041
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Tucker, Georgia, United States, 30084
United States, Illinois
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Arlington Heights, Illinois, United States, 60005
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Aurora, Illinois, United States, 60504
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Bannockburn, Illinois, United States, 60015
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Jerseyville, Illinois, United States, 62052
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Rock Island, Illinois, United States, 61201
United States, Indiana
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Anderson, Indiana, United States, 46011
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Brownsburg, Indiana, United States, 46112
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Elkhart, Indiana, United States, 46514
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Fort Wayne, Indiana, United States, 46845
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Hammond, Indiana, United States, 46320
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Indianapolis, Indiana, United States, 46290
United States, Iowa
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Waterloo, Iowa, United States, 50702
United States, Kansas
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Hutchinson, Kansas, United States, 67502
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Overland Park, Kansas, United States, 66209
United States, Kentucky
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Lexington, Kentucky, United States, 40536
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Louisville, Kentucky, United States, 40207
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Covington, Louisiana, United States, 70433
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Lake Charles, Louisiana, United States, 70601
United States, Maine
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Auburn, Maine, United States, 04210
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Bangor, Maine, United States, 04401
United States, Maryland
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Baltimore, Maryland, United States, 21237
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Columbia, Maryland, United States, 21044
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Lutherville, Maryland, United States, 21093
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Salisbury, Maryland, United States, 21804
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
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Hyannis, Massachusetts, United States, 02601
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Natick, Massachusetts, United States, 01760
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Springfield, Massachusetts, United States, 01199
United States, Michigan
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Cadillac, Michigan, United States, 49601
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Lansing, Michigan, United States, 48910
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Marquette, Michigan, United States, 49855
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Midland, Michigan, United States, 48670
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Novi, Michigan, United States, 48374
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Petoskey, Michigan, United States, 49770
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Pontiac, Michigan, United States, 48341
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Saginaw, Michigan, United States, 48601
United States, Minnesota
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Minneapolis, Minnesota, United States, 55417
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St Cloud, Minnesota, United States, 56303
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St. Paul, Minnesota, United States, 55101 2595
United States, Missouri
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Columbia, Missouri, United States, 65201
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Springfield, Missouri, United States, 65804
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St Louis, Missouri, United States, 63128
United States, Montana
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Great Falls, Montana, United States, 59405
United States, Nebraska
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Omaha, Nebraska, United States, 68114
United States, New Jersey
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Bridgewater, New Jersey, United States, 08807
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Elizabeth, New Jersey, United States, 07202
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Elmer, New Jersey, United States, 08318
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Haddon Heights, New Jersey, United States, 08035
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Mine Hill, New Jersey, United States, 07803
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Ridgewood, New Jersey, United States, 07450
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Sewell, New Jersey, United States, 08080
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Somerset, New Jersey, United States, 08873
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Teaneck, New Jersey, United States, 07666
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Toms River, New Jersey, United States, 08755
United States, New York
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Albany, New York, United States, 12211
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Kingston, New York, United States, 12401
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New York, New York, United States, 10032
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Poughkeepsie, New York, United States, 12601
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Saratoga Springs, New York, United States, 12866
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Southampton, New York, United States, 11968
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Troy, New York, United States, 12180
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Westfield, New York, United States, 14787
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Williamsville, New York, United States, 14221
United States, North Carolina
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Asheville, North Carolina, United States, 28803
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Cary, North Carolina, United States, 27518
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Chapel Hill, North Carolina, United States, 27599
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Elizabeth City, North Carolina, United States, 27909
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Greensboro, North Carolina, United States, 27408
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Hickory, North Carolina, United States, 28602
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Lenoir, North Carolina, United States, 28645
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Wilmington, North Carolina, United States, 28401
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Canton, Ohio, United States, 44708
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Cincinnati, Ohio, United States, 45220
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Cleveland, Ohio, United States, 44195
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Mansfield, Ohio, United States, 44906
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Sandusky, Ohio, United States, 44870
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Toledo, Ohio, United States, 43606
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73135
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Beaver, Pennsylvania, United States, 15009
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Bethlehem, Pennsylvania, United States, 18018
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Camp Hill, Pennsylvania, United States, 17011
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Danville, Pennsylvania, United States, 17822
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Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19152
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Port Matilda, Pennsylvania, United States, 16870
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Pottstown, Pennsylvania, United States, 19464
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Red Lion, Pennsylvania, United States, 17356
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Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
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Cumberland, Rhode Island, United States, 02864
United States, South Carolina
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Columbia, South Carolina, United States, 29204
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Greenville, South Carolina, United States, 29607
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Greer, South Carolina, United States, 29650
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Greeneville, Tennessee, United States, 37745
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Knoxville, Tennessee, United States, 37917
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Nashville, Tennessee, United States, 37203
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Tullahoma, Tennessee, United States, 37388
United States, Texas
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77074
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Kerrville, Texas, United States, 78028
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Kingwood, Texas, United States, 77339
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San Antonio, Texas, United States, 78217
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Tomball, Texas, United States, 77375
United States, Utah
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Bountiful, Utah, United States, 84010
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Murray, Utah, United States, 84123
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Salt Lake City, Utah, United States, 84124
United States, Virginia
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Charlottesville, Virginia, United States, 22908
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Danville, Virginia, United States, 24541
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Falls Church, Virginia, United States, 22042
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Harrisonburg, Virginia, United States, 22801
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Lynchburg, Virginia, United States, 24501
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Roanoke, Virginia, United States, 24014
United States, Washington
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Bellevue, Washington, United States, 98004
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Tacoma, Washington, United States, 98405
United States, West Virginia
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Huntington, West Virginia, United States, 25701
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54303
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Madison, Wisconsin, United States, 53792
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Milwaukee, Wisconsin, United States, 53295
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Oregon, Wisconsin, United States, 53575
Argentina
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Belgrano, Argentina, C1428DCO
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Buenos Aires, Argentina, CBA 1425
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Coronel Suarez, Argentina, B7540GHD
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Córdoba, Argentina, 5006
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San Luis, Argentina, D5702JRS
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San Miguel De Tucuman, Argentina, T4000NIL
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Wollongong, New South Wales, Australia, 2522
Australia, Queensland
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Herston, Queensland, Australia, 4029
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Milton, Queensland, Australia, 4064
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Southport, Queensland, Australia, 4215
Australia, South Australia
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Woodville, South Australia, Australia, 5011
Australia, Tasmania
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Launceston, Tasmania, Australia, 7250
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Geelong, Victoria, Australia, 3220
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Heidelberg, Victoria, Australia, 3084
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Melbourne, Victoria, Australia, 3162
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Windsor, Victoria, Australia, 3183
Austria
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Feldkirch, Austria, 6807
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Vienna, Austria, 1140
Belgium
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Antwerpen, Belgium, 2060
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Brussels, Belgium, 01200
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Huy, Belgium, 4500
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Merksem, Belgium, 2170
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Tienen, Belgium, 3300
Brazil
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Fortaleza, Brazil, 60430-370
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Rio De Janeiro, Brazil, 22271-100
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São Paulo, Brazil, 05403-000
Bulgaria
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Gabrovo, Bulgaria, 5300
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4000
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Smolyan, Bulgaria, 4700
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Sofia, Bulgaria, 1527
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 1V6
Canada, Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C3
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 6V6
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Hamilton, Ontario, Canada, L8L 2X2
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Mississauga, Ontario, Canada, L5B 2P7
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Oshawa, Ontario, Canada, L1J 2J9
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Sarnia, Ontario, Canada, N7T 6K9
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Sudbury, Ontario, Canada, P3E 2N8
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Thunder Bay, Ontario, Canada, P7B 7C7
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Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
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Brossard, Quebec, Canada, J4X 1S4
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Chicoutimi, Quebec, Canada, G7H 5H6
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Gatineau, Quebec, Canada, J8Y6S9
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Greenfield Park, Quebec, Canada, J4V 2G8
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Joilette, Quebec, Canada, J6E 6J2
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Longueuil, Quebec, Canada, J4M 2X1
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Montreal, Quebec, Canada, H1T 1C8
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Saint-Georges, Quebec, Canada, G5Y 4T8
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Sainte-Foy, Quebec, Canada, G1V 4G5
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St-Jerome, Quebec, Canada, J7Z 5T3
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St-Lambert, Quebec, Canada, J4P 2H4
China
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Beijing, China, 100034
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Changsha, China, 410005
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Guang Zhou, China, 510515
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Harbin, China, 150001
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Shanghai, China, 200032
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Shenyang, China, 110004
Czech Republic
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Cesky Krumlov, Czech Republic, 381 01
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Hodonin, Czech Republic, 69501
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Marianske Lazne, Czech Republic, 35301
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Pardubice, Czech Republic, 53002
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Pisek, Czech Republic, 39701
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Prague, Czech Republic, 13000
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Pribram, Czech Republic, 26101
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Teplice, Czech Republic, 41501
Denmark
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Aalborg, Denmark, 9000
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Ballerup, Denmark, 2750
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Copenhagen, Denmark, 2300
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Kobenhavn, Denmark, 2400
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Vejle, Denmark, 7100
Estonia
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Tallinn, Estonia, 10128
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Viljandi, Estonia, 71024
France
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Bordeaux, France, 33000
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Dijon, France, 21000
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Le Coudray, France, 28630
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Paris, France, 75651
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Pessac, France, 33600
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Strasbourg, France, 67091
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Toulouse, France, 31059
Germany
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Altenburg, Germany, 04600
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Bad Krozingen, Germany, 79189
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Berlin, Germany, 13347
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Bielefeld, Germany, 33604
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Dortmund, Germany, 44137
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Dresden, Germany, 01067
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Frankfurt, Germany, 65929
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Heidelberg, Germany, 69120
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Kassel, Germany, 34121
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Mainz, Germany, 55131
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Mönchengladbach, Germany, 41063
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Stuttgart, Germany, 70376
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Tübingen, Germany, D-72076
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Warendorf, Germany, 48231
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Wiesbaden, Germany, 65199
Hong Kong
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Central, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
Hungary
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Bekescsaba, Hungary, 5600
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Budapest, Hungary, 1096
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Debrecen, Hungary, 4025
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Esztergom, Hungary, 2500
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Hodmezovasarhely, Hungary, 6800
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Kalocsa, Hungary, H-6300
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Komarom, Hungary, 2921
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Oroshaza, Hungary, 5901
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Szekszard, Hungary, 7100
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Zalaegerszeg, Hungary, 8900
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91004
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Nazareth, Israel, 16100
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Rehovot, Israel, 76100
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Safed, Israel, 13110
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Tel Hashomer, Israel, 52621
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Tel-Aviv, Israel, 64239
Italy
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Bologna, Italy, 40138
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Castelfranco Veneto, Italy, 31033
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Chieti Scalo, Italy, 66013
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Milano, Italy, 20138
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Napoli, Italy, 80131
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Novara, Italy, 28100
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Parma, Italy, 43100
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Piacenza, Italy, 29100
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San Daniele Del Friuli, Italy, 33038
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Sessa Aurunca, Italy, 81037
Japan
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Aichi, Japan, 470-1192
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Chiba, Japan, 270-2251
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Ehime, Japan, 798-8510
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Fukuoka, Japan, 830-8543
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Gunma, Japan, 377-0061
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Hyogo, Japan, 665-0022
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Ibaraki, Japan, 311-3193
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Ishikawa, Japan, 920-8641
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Kanagawa, Japan, 232-0024
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Kumamoto, Japan, 860-8556
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Kyoto, Japan, 661-0042
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Okinawa, Japan, 901-0493
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Osaka, Japan, 581-0011
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Saitama, Japan, 351-0102
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Shizuoka, Japan, 411-8611
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Tokushima, Japan, 770-8539
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Tokyo, Japan, 152-8902
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Yamaguchi, Japan, 740-8510
Korea, Republic of
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Anyang, Korea, Republic of, 431-070
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Busan, Korea, Republic of, 614-735
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Chungbuk, Korea, Republic of, 361-711
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Daejeon, Korea, Republic of, 301-721
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Gangwon-Do, Korea, Republic of, 200-722
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Goyang, Korea, Republic of, 410-773
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Gwangju, Korea, Republic of, 510-757
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Seoul, Korea, Republic of, 137-701
Lithuania
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, LT-92288
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Vilnius, Lithuania, LT-10323
Mexico
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Aguascalientes, Mexico, 20230
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Chihuahua, Mexico, 31238
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Cul Sinaloa, Mexico, 80020
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Guadalajara, Mexico, 44130
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Huixquilucan, Mexico, 52763
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Mexico City, Mexico, 11850
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Queretaro, Mexico, 76000
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San Luis Potosi, Mexico, 78216
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Tampico, Mexico, 89000
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Tijuana, Mexico, 22500
Netherlands
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Amersfoort, Netherlands, 3818 ES
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Amsterdam, Netherlands, 1105 AZ
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Beverwijk, Netherlands, 1942 LE
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Delft, Netherlands, 2625 AD
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Den Helder, Netherlands, 1782 GZ
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Deventer, Netherlands, 7416 SE
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Drachten, Netherlands, 9202 NN
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Heerlen, Netherlands, 6401CX
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Hilversum, Netherlands, 1213 XZ
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Hoogeveen, Netherlands, 7909AA
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Hoorn, Netherlands, 1625 HV
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Leiden, Netherlands, 2333
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S-Hertogenbosch, Netherlands, 5223 GV
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Tilburg, Netherlands, 5042 AD
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Venlo, Netherlands, 5912 BL
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Waalwijk, Netherlands, 5141 BM
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Zaandam, Netherlands, 1502 DV
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Zwijndrecht, Netherlands, 3331 LZ
New Zealand
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Addington, New Zealand, 8011
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Grafton, New Zealand, 1023
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Hamilton West, New Zealand, 3204
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Newtown, New Zealand, 6021
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Tauranga, New Zealand, 3140
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Westlake, New Zealand, 0620
Poland
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Bydgoszcz, Poland, 85-863
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Gdansk, Poland, 80-126
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Katowice, Poland, 40-752
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Krakow, Poland, 30-510
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Kutno, Poland, 99-300
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Lodz, Poland, 94-255
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Olawa, Poland, 55-200
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Pulawy, Poland, 24-100
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Skierniewice, Poland, 96-100
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Sobotka, Poland, 55050
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Warsaw, Poland, 04-730
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Wroclaw, Poland, 51-112
Puerto Rico
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Ponce, Puerto Rico, 00717-1322
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San Juan, Puerto Rico, 00909
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Trujillo Alto, Puerto Rico, 00976
Romania
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Braila, Romania, 810249
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Bucharest, Romania, 022328
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Buzau, Romania, 120203
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Focsani, Romania, 620034
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Oradea, Romania, 410169
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Kemerovo, Russian Federation, 650002
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Moscow, Russian Federation, 111020
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Saint Petersburg, Russian Federation, 196105
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Smolensk, Russian Federation, 214019
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Tomsk, Russian Federation, 196105
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Yaroslavl, Russian Federation, 150002
Slovakia
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Bardejov, Slovakia, 08501
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Bratislava, Slovakia, 85101
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Kralovsky Chlmec, Slovakia, 07701
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Nitra, Slovakia, 949 01
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Presov, Slovakia, 080 01
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Zilina, Slovakia, 010 01
South Africa
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Alberton, South Africa, 1449
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Bellville, South Africa, 7530
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Bloemfontein, South Africa, 9300
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Goodwood, South Africa, 7460
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Johannesburg, South Africa, 1460
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Kuilsriver, South Africa, 7580
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Newlands West, South Africa, 4035
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Parktown West, South Africa, 2193
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Worcester, South Africa, 6850
Spain
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Ciudad Real, Spain, 13005
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Cordoba, Spain, 14004
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L´Hospitalet De Llobregat, Spain, 08907
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Madrid, Spain, 28040
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Málaga, Spain, 29010
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Palma De Mallorca, Spain, 07198
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Pamplona, Spain, 31008
Sweden
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Lund, Sweden, 22221
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Malmö, Sweden, 20502
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Stockholm, Sweden, 11157
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Östersund, Sweden, 83183
Switzerland
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Lugano, Switzerland, CH-6900
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Zürich, Switzerland, CH-8091
Taiwan
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Kaohsiung, Taiwan, 807
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Kaohsiung City, Taiwan, 83301
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Kuei Shan Hsiang, Taiwan, 33305
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Taichung, Taiwan, 40705
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Taichung City, Taiwan, 40201
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Taipei, Taiwan, 111
Turkey
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Ankara, Turkey, 06520
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Konya, Turkey, 42250
Ukraine
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Kyiv, Ukraine, 2091
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Lutsk, Ukraine, 43024
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Poltava, Ukraine, 36038
United Kingdom
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St. Stephen, Cornwall, United Kingdom, PL26 7RL
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Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
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Barnet, Herts, United Kingdom, EN5 3DJ
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Stevenage, Herts, United Kingdom, SG4 7NH
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Tooting, London, United Kingdom, SW17 ORE
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Wellingborough, Northants, United Kingdom, NN8 4RW
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Dudley, West Midlands, United Kingdom, DY1 2HQ
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Bath, United Kingdom, BA2 4BY
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Frome, United Kingdom, BA11 1EZ
Sponsors and Collaborators
Eli Lilly and Company
The Cleveland Clinic
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: NCT01687998     History of Changes
Other Study ID Numbers: 11949, I1V-MC-EIAN
Study First Received: September 12, 2012
Last Updated: December 19, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Peru: Instituto Nacional de Salud
Poland: Ethics Committee
Poland: The Central Register of Clinical Trials
Romania: National Agency for Medicines and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014