Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
2 other identifiers
interventional
2,711
28 countries
423
Brief Summary
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2008
Typical duration for phase_3
423 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 25, 2013
CompletedNovember 25, 2013
October 1, 2013
4.3 years
March 5, 2008
August 19, 2013
October 30, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Day 1 up to 12 Months
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
Day 1 up to 12 months
Secondary Outcomes (20)
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
Day 1 up to 12 Months
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
Day 1 up to 12 Months
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
Day 1 up to 12 Months
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
Day 1 up to 12 Months
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
Day 1 up to 12 Months
- +15 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2.5 mg
2
EXPERIMENTAL5.0 mg
3
ACTIVE COMPARATOR0 mg
Interventions
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18 years of age;
- Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
- Anticoagulant treatment completed
- No recurrence of Venous Thromboembolism (VTE)
You may not qualify if:
- Subjects with indications for long-term treatment with a vitamin K antagonist
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Impaired kidney or liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (428)
Alabama Clinical Therapeutics, Llc
Birmingham, Alabama, 35235, United States
Cardiovascular Consultants, Ltd.
Phoenix, Arizona, 85032, United States
Robert J. Bloomberg, Md, Pc
Tempe, Arizona, 85283, United States
Fort Smith Lung Center
Fort Smith, Arkansas, 72901, United States
Beaver Medical Group
Banning, California, 92220, United States
Scripps Clinic/Scripps Health And Green Hospital
La Jolla, California, 92037, United States
Healthcare Partners Medical Group
Los Angeles, California, 90015, United States
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
Palm Springs, California, 92262, United States
Indus Clinical Research Institute, Inc.
Pomona, California, 91767, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Harbor Ucla Medical Center
Torrance, California, 90509, United States
Progressive Clinical Research
Vista, California, 92083, United States
Rocky Mountain Internal Medicine
Aurora, Colorado, 80012, United States
New West Physicians
Golden, Colorado, 80401, United States
Alfieri Cardiology
Newark, Delaware, 19713, United States
Bay Pines Va Healthcare Systems
Bay Pines, Florida, 33744, United States
Research Alliance, Inc.
Clearwater, Florida, 33756, United States
St. Francis Sleep Allergy & Lung Institute
Clearwater, Florida, 33765, United States
Berma Research Group
Fort Lauderdale, Florida, 33316, United States
Healthworx
Hollywood, Florida, 33021, United States
Hematology Oncology Associates
Loxahatchee Groves, Florida, 33470, United States
South Miami Heart Center
Miami, Florida, 33143, United States
Physicians Regional Medical Group
Naples, Florida, 34119, United States
Richard A. Mclean M.D., P.A.
Plantation, Florida, 33317, United States
Tampa Clinical Research
Tampa, Florida, 33624, United States
Primary Care Of The Treasure Coast, Inc.
Vero Beach, Florida, 32960, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Vascular Surgical Associates, Pc
Austell, Georgia, 30106, United States
Atlanta Institute For Medical Research, Inc
Decatur, Georgia, 30030, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, 30046, United States
Boise Orthopedic Clinic
Boise, Idaho, 83706, United States
Saltzer Medical Group
Nampa, Idaho, 83686, United States
Infectious Disease Of Indiana Psc
Carmel, Indiana, 46032, United States
Office Of:Eugene C. Fletcher, Md
New Albany, Indiana, 47150, United States
Heartland Vascular Medicine And Surgery
Windsor Heights, Iowa, 50324, United States
Kentucky Lung Clinic
Hazard, Kentucky, 41701, United States
Owensboro Heart & Vascular
Owensboro, Kentucky, 42303, United States
Pen Bay Medical Center
Rockport, Maine, 04856, United States
Anne Arundel Health System Research Institute, Inc.
Annapolis, Maryland, 21401, United States
Cape Cod Research Institute
Hyannis, Massachusetts, 02601, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Mercury Street Medical Group, Pllc
Butte, Montana, 59701, United States
Great Falls Clinic, Llp
Great Falls, Montana, 59405, United States
Internal Medical Associates Of Grand Island, P.C
Grand Island, Nebraska, 68803, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Kaleida Health System
Buffalo, New York, 14209, United States
Goshen Medical Associates
Goshen, New York, 10924, United States
Sjh Cardiology Associates
Liverpool, New York, 13088, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
New York Medical College
Valhalla, New York, 10595, United States
Thomas L. Ortel, Md, Phd
Durham, North Carolina, 27710, United States
Valley Internal Medicine
Fayetteville, North Carolina, 28304, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Whiteville Medical Associates, P.A.
Whiteville, North Carolina, 28472, United States
Wilmington Medical Research
Wilmington, North Carolina, 28401, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Community Health Care, Inc.
Canal Fulton, Ohio, 44614, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Remington Davis Inc.
Columbus, Ohio, 43215, United States
Jobst Vascular Center At The Toledo Hospital
Toledo, Ohio, 43606, United States
Cor Clinical Research, Llc
Oklahoma City, Oklahoma, 73103, United States
Pma Medical Specialists
Phoenixville, Pennsylvania, 19460, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414, United States
Greenville Hospital System
Greenville, South Carolina, 29615, United States
Three Rivers Medical Associates, Pa
Irmo, South Carolina, 29063, United States
Clinical Research Authority, Llc
Murrells Inlet, South Carolina, 29576, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Amarillo Heart Clinical Research Institute Inc.
Amarillo, Texas, 79106, United States
Corsicana Medical Research
Corsicana, Texas, 75110, United States
Ankur Doshi, Md
Houston, Texas, 77024, United States
Northwest Heart Center
Tomball, Texas, 77375, United States
Tanner Clinic
Layton, Utah, 84041, United States
University Of Utah Hospital
Salt Lake City, Utah, 84132, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
Sentara York Clinical Research
Norfolk, Virginia, 23510, United States
Lake Washington Vascular, Pllc
Bellevue, Washington, 98004, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
Medical Assoicates Inc.
Menomonee Falls, Wisconsin, 53051, United States
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Buenos Aires, Buenos Aires, C1122AAL, Argentina
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Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Buenos Aires, Buenos Aires, C1431FWO, Argentina
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Capital Federal, Buenos Aires, C1426ANZ, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, 1093 AAS, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1180AAX, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1437JCP, Argentina
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Ciudad de Buenos Aires, Buenos Aires, C1034ACO, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Corrientes, Corrientes Province, 3400, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Córdoba, Córdoba Province, X5000JHQ, Argentina
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Rosario, Santa Fe Province, S2000CVB, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2002KDS, Argentina
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Garran, Australian Capital Territory, 2605, Australia
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Kogarah, New South Wales, 2217, Australia
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Lismore, New South Wales, 2480, Australia
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St Leonards, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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Kippa-Ring, Queensland, 4021, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Bedford Park, South Australia, 5042, Australia
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Launceston, Tasmania, 7250, Australia
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Box Hill, Victoria, 3128, Australia
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Clayton, Victoria, 3168, Australia
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Footscray, Victoria, 3011, Australia
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Parkville, Victoria, 3050, Australia
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Richmond, Victoria, 3121, Australia
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Ringwood East, Victoria, 3135, Australia
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Windsor, Victoria, 3181, Australia
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Perth, Western Australia, 6000, Australia
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Graz, 8036, Austria
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Innsbruck, A-6020, Austria
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Vienna, 1090, Austria
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Vienna, 1100, Austria
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Vienna, 1140, Austria
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Salvador, Estado de Bahia, 40144 900, Brazil
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Brasília, Federal District, 70335, Brazil
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Belo Horizonte - Mg, Minas Gerais, 30130, Brazil
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Belo Horizonte - Mg, Minas Gerais, 30150, Brazil
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Curitiba, Paraná, 80030, Brazil
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Curitiba, Paraná, 80050, Brazil
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Curitiba, Paraná, 80810, Brazil
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Curitiba, Paraná, 81520, Brazil
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Rio de Janeiro, Rio de Janeiro, 20551, Brazil
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Rio Janeiro, Rio de Janeiro, 22280, Brazil
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Port Alegre, Rio Grande do Sul, 90020, Brazil
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Porto Alegre, Rio Grande do Sul, 90035, Brazil
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Porto Alegre, Rio Grande do Sul, 90610, Brazil
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Porto Alegre, Rio Grande do Sul, 9110270, Brazil
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Botucatu, São Paulo, 18618, Brazil
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Campinas, São Paulo, 13083, Brazil
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Santo Andre - Sp, São Paulo, 09060, Brazil
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São José do Rio Preto, São Paulo, 15015, Brazil
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São José do Rio Preto, São Paulo, 15090, Brazil
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São Paulo, São Paulo, 01323, Brazil
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São Paulo, São Paulo, 01509, Brazil
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São Paulo, São Paulo, 04005, Brazil
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São Paulo, São Paulo, 05403, Brazil
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Edmonton, Alberta, T5H 4B9, Canada
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Edmonton, Alberta, T5X 3N5, Canada
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Edmonton, Alberta, Tsa 4l8, Canada
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Kelowna, British Columbia, V1Y 9L8, Canada
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Hamilton, Ontario, L8S 4K1, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Punta Arenas, Magallanes Antartica, 6212296, Chile
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Temuco, Región de la Araucanía, 4781173, Chile
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Viña del Mar, Región de Valparaíso, 2520000, Chile
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Independencia, Santiago Metropolitan, XXXXX, Chile
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Santiago, Santiago Metropolitan, 7500520, Chile
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Santiago, Santiago Metropolitan, 7600448, Chile
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Santiago, Santiago Metropolitan, 7980378, Chile
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Santiago, Santiago Metropolitan, 8330024, Chile
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Kladno, 272 59, Czechia
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Litomyšl, 570 14, Czechia
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Městec Králové, 289 03, Czechia
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Ostrava Vitkovice, 703 00, Czechia
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Pilsen, 323 33, Czechia
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Prague, 110 00, Czechia
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Prague, 118 33, Czechia
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Prague, 120 00, Czechia
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Prague, 121 11, Czechia
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Prague, 128 08, Czechia
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Prague, 140 21, Czechia
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Prague, 158 00, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Arhus C, 8000, Denmark
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Brædstrup, 8740, Denmark
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Esbjerg, 6700, Denmark
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Frederiksberg, 2000, Denmark
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Hellerup, 2900, Denmark
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Herning, 7400, Denmark
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Hilleroed, 3400, Denmark
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Næstved, 4700, Denmark
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Silkeborg, 8600, Denmark
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Arras, 62022, France
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Besançon, 25000, France
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Brest, 29609, France
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Clamart, 92141, France
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Clermont-Ferrand, 63003, France
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Dijon, 21079, France
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Grenoble, 38043, France
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Le Kremlin-Bicêtre, 94275, France
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Lille, 59020, France
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Limoges, 87042, France
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Lyon, 69437, France
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Nantes, 44093, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Vernon, 27200, France
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Berlin, 10117, Germany
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Berlin, 10787, Germany
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Berlin, 14050, Germany
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Bochum, 44791, Germany
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Bonn, 53115, Germany
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Cologne, 50937, Germany
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Dortmund, 44137, Germany
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Dresden, 01067, Germany
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Dresden, 01307, Germany
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Erfurt, 99089, Germany
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Frankfurt, 60596, Germany
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Göttingen, 37075, Germany
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Karlsbad, 76307, Germany
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Krefeld, 47805, Germany
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Ludwigshafen, 67063, Germany
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Mannheim, 68161, Germany
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Mannheim, 68165, Germany
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Mannheim, 68167, Germany
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Munich, 80336, Germany
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München, 80331, Germany
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Hong Kong, Hong Kong
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Shatin, N.T, Hong Kong
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Hyderabad, Andhra Pradesh, 500 082, India
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Hyderabad, Andhra Pradesh, 500034, India
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Ahmedabad, Gujarat, 380006, India
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Gurgaon, Haryana, 122001, India
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Bangalore, Karnataka, 560054, India
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Bengaluru, Karnataka, 560017, India
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Kochi, Kerala, 682041, India
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Pune, Maharashtra, 411001, India
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New Dehli, New Dehli, 110025, India
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Mohali, Punjab, 160062, India
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Ludhiana, Tagore Nagar, 141001, India
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Chennai, Tamil Nadu, 600 006, India
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Ahmedabad, 380015, India
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Bangalore, 560052, India
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Bangalore, Karnataka, 560034, India
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Chennai, 600 003, India
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Chennai, 600 006, India
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Afula, 18101, Israel
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Giv‘atayim, 53488, Israel
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Hadera, 38101, Israel
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Haifa, 31048, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 44281, Israel
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Kiryat Hadassah, 91120, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49100, Israel
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Safed, 13100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Bollate, 20021, Italy
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Bologna, 40138, Italy
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Chieti Scalo, 66013, Italy
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Cosenza, 87100, Italy
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Ferrara, 44100, Italy
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Florence, 50134, Italy
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Genova, 16128, Italy
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Milan, 20132, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Pavia, 27100, Italy
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Perugia, 06132, Italy
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Piacenza, 29100, Italy
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Pisa, 56124, Italy
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Roma, 00168, Italy
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Rozzano (Mi), 20089, Italy
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San Daniele Del Friuli (Ud), 33038, Italy
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Udine, 33100, Italy
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Venezia, 30122, Italy
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Vicenza, 36100, Italy
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Vittorio Veneto (Tv), 31029, Italy
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Aguascalientes, Aguascalientes, 20230, Mexico
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Chihuahua City, Chihuahua, 31203, Mexico
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Durango, Durango, 34080, Mexico
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Tijuana, Estado de Baja California, 22500, Mexico
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León, Guanajuato, 37320, Mexico
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Guadalajara, Jalisco, 44130, Mexico
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Guadalajara, Jalisco, 44200, Mexico
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Guadalajara, Jalisco, 44280, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Monterrey, Nuevo León, 64000, Mexico
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Monterrey, Nuevo León, 64710, Mexico
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Puebla City, Puebla, 72000, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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San Luis Potosí City, San Luis Potosí, 78200, Mexico
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San Luis Potosí City, San Luis Potosí, 78240, Mexico
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Culiacán, Sinaloa, 80020, Mexico
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Culiacán, Sinaloa, 80230, Mexico
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Xalapa, Veracruz, 91020, Mexico
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Ålesund, 6026, Norway
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Fredrikstad, 1606, Norway
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Gjettum, 1346, Norway
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Gjøvik, 2819, Norway
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Hamar, 2318, Norway
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Oslo, 0407, Norway
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Cavite, 4114, Philippines
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Davao City, 8000, Philippines
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Pasig, 1600, Philippines
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Quezon City, 1102, Philippines
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Arkonska 4, 71455, Poland
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-168, Poland
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Bydgoszcz, 85-650, Poland
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Bydgoszcz, 85-681, Poland
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Gdansk, 80-803, Poland
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Gdynia, 81-348, Poland
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Gdynia, 81-423, Poland
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Lodz, 90-153, Poland
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Lublin, 20-081, Poland
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Lublin, 20-718, Poland
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Poznan, 61-848, Poland
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Przeworsk, 37-200, Poland
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Szczecin, 70-111, Poland
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Tarnobrzeg, 39-400, Poland
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Warsaw, 01-138, Poland
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Warsaw, 01-809, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-018, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 51-124, Poland
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Wroclaw, 53-114, Poland
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Guarda, 6301-857, Portugal
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Lisbon, 1769-001, Portugal
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San Juan, 00909, Puerto Rico
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San Juan, 00921, Puerto Rico
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Baia Mare, 430031, Romania
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Bucharest, 022328, Romania
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Bucharest, 030171, Romania
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Bucharest, 050098, Romania
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Târgu Mureş, 540136, Romania
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Arkhangelsk, 163045, Russia
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Kemerovo, 650002, Russia
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Moscow, 105077, Russia
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Moscow, 111539, Russia
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Moscow, 119049, Russia
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Moscow, 127473, Russia
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Novosibirsk, 630055, Russia
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Novosibirsk, 630090, Russia
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Rostov-on-Don, 344022, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 199106, Russia
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Samara, 443010, Russia
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Saratov, 410012, Russia
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Saratov, 410028, Russia
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Tomsk, 634012, Russia
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Yaroslavl, 150062, Russia
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Singapore, 169608, Singapore
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Singapore, 308433, Singapore
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Bloemfontein, Free State, 9301, South Africa
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Centurion, Gauteng, 0157, South Africa
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Parktown, Gauteng, 2193, South Africa
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Pretoria, Gauteng, 0083, South Africa
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Pretoria, Gauteng, 0084, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Pietermaritzburg, KwaZulu-Natal, 3201, South Africa
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Bellville, Western Cape, 7530, South Africa
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George, Western Cape, 6529, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Worcester, Western Cape, 6850, South Africa
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Busan, 602-702, South Korea
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Jongno-Gu, 110-774, South Korea
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Seoul, 120752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-040, South Korea
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Seoul, 138736, South Korea
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Torrevieja, Alicante, 03186, Spain
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Badalona, Barcelona, 08916, Spain
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Majadahonda, Madrid, 28222, Spain
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San Sebastián de los Reyes, Madrid, 28702, Spain
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Cadiz, 11009, Spain
Local Institution
Getafe, 28905, Spain
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Girona, 17007, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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León, 24008, Spain
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Madrid, 28007, Spain
Local Institution
Madrid, 28029, Spain
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Madrid, 28040, Spain
Local Institution
Madrid, 28041, Spain
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Mourente, 36071, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Sant Boi de Llobregat, 08830, Spain
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Tarragona, 43007, Spain
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Toledo, 45071, Spain
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Valencia, 46026, Spain
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Chernihiv, 14034, Ukraine
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Dnipropetrovsk, 49000, Ukraine
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Donetsk, 83045, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
Local Institution
Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61018, Ukraine
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Kyiv, 03680, Ukraine
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Lviv, 79010, Ukraine
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Odesa, 65117, Ukraine
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Ternopil, 46000, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhia, 69035, Ukraine
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Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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London, Greater London, SE5 9RS, United Kingdom
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London, Greater London, SW17 0QT, United Kingdom
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Manchester, Greater Manchester, M23 9LT, United Kingdom
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Hull, Humberside, HU3 2JZ, United Kingdom
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Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
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Bury St Edmunds, Suffolk, IP30 9QU, United Kingdom
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Coventry, West Midlands, CV2 2DX, United Kingdom
Local Institution
Dudley, West Midlands, DY1 2HQ, United Kingdom
Related Publications (3)
Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
PMID: 35570249DERIVEDLiu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.
PMID: 26446706DERIVEDAgnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.
PMID: 23216615DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 12, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 25, 2013
Results First Posted
October 25, 2013
Record last verified: 2013-10