Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

Last updated: February 8, 2019
Sponsor: Daiichi Sankyo, Inc.
Overall Status: Completed

Phase

3

Condition

Atrial Fibrillation

Stroke

Claudication

Treatment

N/A

Clinical Study ID

NCT00781391
DU176b-C-U301
  • Ages > 21
  • All Genders

Study Summary

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 21 years of age or older; male or female.

  • Able to provide written informed consent.

  • History of documented AF within the prior 12 months

  • A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion

Exclusion Criteria:

  • Transient atrial fibrillation secondary to other reversible disorders

  • Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or amechanical heart valve

  • Subjects with any contraindication for anticoagulant agents;

  • Subjects with conditions associated with high risk of bleeding or have known orsuspected hereditary or acquired bleeding disorders

  • Females of childbearing potential including the following:

  • Females with a history of tubal-ligation

  • Females less than 2 years post-menopausal

Study Design

Total Participants: 21105
Study Start date:
November 01, 2008
Estimated Completion Date:
May 31, 2013

Connect with a study center

  • Bahia Blanca,
    Argentina

    Site Not Available

  • Buenos Aires,
    Argentina

    Site Not Available

  • Cordoba,
    Argentina

    Site Not Available

  • Corrientes,
    Argentina

    Site Not Available

  • Formosa,
    Argentina

    Site Not Available

  • Godoy Cruz,
    Argentina

    Site Not Available

  • Jujuy,
    Argentina

    Site Not Available

  • Mar del Plata,
    Argentina

    Site Not Available

  • Mendoza,
    Argentina

    Site Not Available

  • Paraguay,
    Argentina

    Site Not Available

  • Provincia De Chaco,
    Argentina

    Site Not Available

  • Provincia De Rio Negro,
    Argentina

    Site Not Available

  • Provincia De Salta,
    Argentina

    Site Not Available

  • San Luis,
    Argentina

    Site Not Available

  • Santa Fe,
    Argentina

    Site Not Available

  • Sante Fe,
    Argentina

    Site Not Available

  • Tucuman,
    Argentina

    Site Not Available

  • Broken Hill, New South Wales
    Australia

    Site Not Available

  • East Gosford, New South Wales
    Australia

    Site Not Available

  • Carina Heights, Queensland
    Australia

    Site Not Available

  • Milton, Queensland
    Australia

    Site Not Available

  • Adelaide, South Australia
    Australia

    Site Not Available

  • Frankston, Victoria
    Australia

    Site Not Available

  • Ashford,
    Australia

    Site Not Available

  • Camperdown,
    Australia

    Site Not Available

  • Elizabeth Vale,
    Australia

    Site Not Available

  • Joondalup,
    Australia

    Site Not Available

  • Melbourne,
    Australia

    Site Not Available

  • Parkville,
    Australia

    Site Not Available

  • Perth,
    Australia

    Site Not Available

  • Antwerpen,
    Belgium

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  • Arlon,
    Belgium

    Site Not Available

  • Brugge,
    Belgium

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  • Bruxelles,
    Belgium

    Site Not Available

  • Genk,
    Belgium

    Site Not Available

  • Hasselt,
    Belgium

    Site Not Available

  • Leuven,
    Belgium

    Site Not Available

  • Liege,
    Belgium

    Site Not Available

  • Mechelen,
    Belgium

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  • Merksem,
    Belgium

    Site Not Available

  • Moerkerke,
    Belgium

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  • Montegnee,
    Belgium

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  • Mousron,
    Belgium

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  • Torhout,
    Belgium

    Site Not Available

  • Veurne,
    Belgium

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  • Wetteren,
    Belgium

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  • Belo Horizonte,
    Brazil

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  • Blumenau,
    Brazil

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  • Brasilia,
    Brazil

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  • Campina Grande do Sul,
    Brazil

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  • Campinas,
    Brazil

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    Brazil

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    Brazil

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    Brazil

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  • Lajeados,
    Brazil

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  • Passo Fundo,
    Brazil

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  • Recife,
    Brazil

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    Brazil

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    Brazil

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  • Salvador,
    Brazil

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    Brazil

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    Brazil

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    Bulgaria

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    Bulgaria

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    Bulgaria

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    Bulgaria

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    Bulgaria

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    Bulgaria

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    Bulgaria

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    Bulgaria

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  • Calgary, Alberta
    Canada

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    Canada

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    Canada

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  • Split,
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  • Varazdin,
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  • Zagreb,
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  • Benatky nad Jizerou,
    Czechia

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  • Benesov,
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  • Bilovec,
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  • Brno,
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  • Cesky Krumlov,
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  • Jindrichuv Hradec,
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  • Marianske Lazne,
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  • Plzen,
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  • Praha,
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  • Pribram,
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  • Revnice,
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    Czechia

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  • Slany,
    Czechia

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  • Teplice,
    Czechia

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  • Usti nad Labem,
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  • Aarhus N,
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  • Glostrup,
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  • Horsens,
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  • Kobenhaven,
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  • Kobenhavn,
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  • Haabneeme, Harjumaa
    Estonia

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  • Puusepa, Tartu
    Estonia

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  • Parnu,
    Estonia

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  • Tallin,
    Estonia

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  • Tallinn,
    Estonia

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  • Tartu,
    Estonia

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  • Jyvaskyla,
    Finland

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  • Kuopio,
    Finland

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  • Lappeenranta,
    Finland

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  • Oulu,
    Finland

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  • Seinajoki,
    Finland

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  • Tampere,
    Finland

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  • Abbeville,
    France

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    France

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  • Brest,
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  • Cambrai,
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  • La Roche sur Yon,
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    Germany

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  • Hamburg,
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  • Athens,
    Greece

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    Greece

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    Greece

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    Greece

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    Greece

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    Guatemala

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    Guatemala

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    Guatemala

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    Guatemala

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    Guatemala

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    Guatemala

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    Guatemala

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  • Ajka,
    Hungary

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    Site Not Available

  • Lexington Park, Maryland
    United States

    Site Not Available

  • Rockville, Maryland
    United States

    Site Not Available

  • Salisbury, Maryland
    United States

    Site Not Available

  • Towson, Maryland
    United States

    Site Not Available

  • Westminster, Maryland
    United States

    Site Not Available

  • Ayer, Massachusetts
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Concord, Massachusetts
    United States

    Site Not Available

  • empty

    E. Bridgewater, Massachusetts
    United States

    Site Not Available

  • East Bridgewater, Massachusetts
    United States

    Site Not Available

  • Haverhill, Massachusetts
    United States

    Site Not Available

  • Methuen, Massachusetts
    United States

    Site Not Available

  • Worcester, Massachusetts
    United States

    Site Not Available

  • Bay City, Michigan
    United States

    Site Not Available

  • Benzonia, Michigan
    United States

    Site Not Available

  • Chelsea, Michigan
    United States

    Site Not Available

  • Commerce, Michigan
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Grand Rapids, Michigan
    United States

    Site Not Available

  • Interlochen, Michigan
    United States

    Site Not Available

  • Kalamazoo, Michigan
    United States

    Site Not Available

  • Lapeer, Michigan
    United States

    Site Not Available

  • Midland, Michigan
    United States

    Site Not Available

  • Rochester Hills, Michigan
    United States

    Site Not Available

  • Saginaw, Michigan
    United States

    Site Not Available

  • Troy, Michigan
    United States

    Site Not Available

  • Warren, Michigan
    United States

    Site Not Available

  • Golden Valley, Minnesota
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • Saint Paul, Minnesota
    United States

    Site Not Available

  • empty

    St. Paul, Minnesota
    United States

    Site Not Available

  • Biloxi, Mississippi
    United States

    Site Not Available

  • Chesterfield, Missouri
    United States

    Site Not Available

  • Joplin, Missouri
    United States

    Site Not Available

  • Kansas City, Missouri
    United States

    Site Not Available

  • Saint Charles, Missouri
    United States

    Site Not Available

  • Saint Louis, Missouri
    United States

    Site Not Available

  • empty

    St. Charles, Missouri
    United States

    Site Not Available

  • empty

    St. Louis, Missouri
    United States

    Site Not Available

  • Kalispell, Montana
    United States

    Site Not Available

  • Fremont, Nebraska 68025
    United States

    Site Not Available

  • Grand Island, Nebraska
    United States

    Site Not Available

  • Lincoln, Nebraska
    United States

    Site Not Available

  • Omaha, Nebraska
    United States

    Site Not Available

  • Henderson, Nevada
    United States

    Site Not Available

  • Belvidere, New Jersey
    United States

    Site Not Available

  • Brick, New Jersey
    United States

    Site Not Available

  • Bridgewater, New Jersey
    United States

    Site Not Available

  • Browns Mills, New Jersey
    United States

    Site Not Available

  • Cherry Hill, New Jersey
    United States

    Site Not Available

  • Elizabeth, New Jersey
    United States

    Site Not Available

  • Haddon Heights, New Jersey
    United States

    Site Not Available

  • Hamilton, New Jersey
    United States

    Site Not Available

  • Mine Hill, New Jersey
    United States

    Site Not Available

  • empty

    Ocean, New Jersey
    United States

    Site Not Available

  • Ocean City, New Jersey
    United States

    Site Not Available

  • Passaic, New Jersey
    United States

    Site Not Available

  • Ridgewood, New Jersey
    United States

    Site Not Available

  • Toms River, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Brooklyn, New York
    United States

    Site Not Available

  • Buffalo, New York
    United States

    Site Not Available

  • Cortlandt Manor, New York
    United States

    Site Not Available

  • Hawthorne, New York
    United States

    Site Not Available

  • Jamaica, New York
    United States

    Site Not Available

  • Mineola, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • North Massapequa, New York
    United States

    Site Not Available

  • Saratoga Springs, New York
    United States

    Site Not Available

  • Cary, North Carolina
    United States

    Site Not Available

  • Chapel Hill, North Carolina
    United States

    Site Not Available

  • Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Mooresville, North Carolina
    United States

    Site Not Available

  • Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Morganton, North Carolina
    United States

    Site Not Available

  • Oxford, North Carolina
    United States

    Site Not Available

  • Pinehurst, North Carolina
    United States

    Site Not Available

  • Statesville, North Carolina
    United States

    Site Not Available

  • Winston-Salem, North Carolina
    United States

    Site Not Available

  • Fargo, North Dakota
    United States

    Site Not Available

  • Oakes, North Dakota
    United States

    Site Not Available

  • Akron, Ohio
    United States

    Site Not Available

  • Canal Fulton, Ohio
    United States

    Site Not Available

  • Canton, Ohio
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Columbus, Ohio
    United States

    Site Not Available

  • Cuyahoga Falls, Ohio
    United States

    Site Not Available

  • Dayton, Ohio
    United States

    Site Not Available

  • Fairfield, Ohio
    United States

    Site Not Available

  • Marion, Ohio
    United States

    Site Not Available

  • Middletown, Ohio
    United States

    Site Not Available

  • Pitsburg, Ohio
    United States

    Site Not Available

  • Thornville, Ohio
    United States

    Site Not Available

  • Toledo, Ohio
    United States

    Site Not Available

  • Willoughby Hills, Ohio
    United States

    Site Not Available

  • Bartlesville, Oklahoma
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Bend, Oregon
    United States

    Site Not Available

  • Corvallis, Oregon
    United States

    Site Not Available

  • Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Beaver, Pennsylvania
    United States

    Site Not Available

  • Chester, Pennsylvania
    United States

    Site Not Available

  • Clymer, Pennsylvania
    United States

    Site Not Available

  • Doylestown, Pennsylvania
    United States

    Site Not Available

  • Ephrata, Pennsylvania
    United States

    Site Not Available

  • Feasterville, Pennsylvania
    United States

    Site Not Available

  • Fleetwood, Pennsylvania 19522
    United States

    Site Not Available

  • Johnstown, Pennsylvania
    United States

    Site Not Available

  • Lancaster, Pennsylvania
    United States

    Site Not Available

  • Lewistown, Pennsylvania
    United States

    Site Not Available

  • Newport, Pennsylvania
    United States

    Site Not Available

  • Norristown, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Pottstown, Pennsylvania
    United States

    Site Not Available

  • Scranton, Pennsylvania
    United States

    Site Not Available

  • Sellersville, Pennsylvania
    United States

    Site Not Available

  • Somerset, Pennsylvania
    United States

    Site Not Available

  • State College, Pennsylvania
    United States

    Site Not Available

  • Uniontown, Pennsylvania
    United States

    Site Not Available

  • Wilkes-Barre, Pennsylvania
    United States

    Site Not Available

  • Wynnewood, Pennsylvania
    United States

    Site Not Available

  • Yardley, Pennsylvania
    United States

    Site Not Available

  • Providence, Rhode Island
    United States

    Site Not Available

  • Anderson, South Carolina
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Columbia, South Carolina
    United States

    Site Not Available

  • Florence, South Carolina
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Greer, South Carolina 29651
    United States

    Site Not Available

  • Mount Pleasant, South Carolina
    United States

    Site Not Available

  • empty

    Mt. Pleasant, South Carolina
    United States

    Site Not Available

  • Spartanburg, South Carolina 29302
    United States

    Site Not Available

  • Summerville, South Carolina
    United States

    Site Not Available

  • Taylors, South Carolina
    United States

    Site Not Available

  • Walterboro, South Carolina
    United States

    Site Not Available

  • Rapid City, South Dakota
    United States

    Site Not Available

  • Jackson, Tennessee
    United States

    Site Not Available

  • Johnson City, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Oak Ridge, Tennessee
    United States

    Site Not Available

  • Arlington, Texas
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Carrollton, Texas
    United States

    Site Not Available

  • Corsicana, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • Georgetown, Texas
    United States

    Site Not Available

  • Grapevine, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Lubbock, Texas
    United States

    Site Not Available

  • McAllen, Texas
    United States

    Site Not Available

  • Odessa, Texas
    United States

    Site Not Available

  • Plano, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Tomball, Texas
    United States

    Site Not Available

  • Wichita Falls, Texas
    United States

    Site Not Available

  • Provo, Utah
    United States

    Site Not Available

  • West Valley City, Utah 84120
    United States

    Site Not Available

  • Danville, Virginia
    United States

    Site Not Available

  • Hopewell, Virginia
    United States

    Site Not Available

  • Newport News, Virginia
    United States

    Site Not Available

  • Norfolk, Virginia 23502
    United States

    Site Not Available

  • Richmond, Virginia 23294
    United States

    Site Not Available

  • Springfield, Virginia
    United States

    Site Not Available

  • Suffolk, Virginia
    United States

    Site Not Available

  • Virginia Beach, Virginia
    United States

    Site Not Available

  • Winchester, Virginia
    United States

    Site Not Available

  • Bellevue, Washington
    United States

    Site Not Available

  • Kirkland, Washington
    United States

    Site Not Available

  • Renton, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Spokane, Washington
    United States

    Site Not Available

  • Tacoma, Washington
    United States

    Site Not Available

  • Clarksburg, West Virginia
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

  • Manitowoc, Wisconsin
    United States

    Site Not Available

  • Menomonee Falls, Wisconsin
    United States

    Site Not Available

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