Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

NCT ID: NCT00643201

Last Updated: 2014-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed Description

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Conditions

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Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apixaban

apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

warfarin

Intervention Type DRUG

tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

Placebo for apixaban

Intervention Type DRUG

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

Enoxaparin + Warfarin

Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.

Group Type EXPERIMENTAL

Placebo for enoxaparin

Intervention Type DRUG

solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

Placebo for warfarin

Intervention Type DRUG

tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

apixaban

Intervention Type DRUG

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Interventions

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Enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

Intervention Type DRUG

warfarin

tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

Intervention Type DRUG

Placebo for apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

Intervention Type DRUG

Placebo for enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

Intervention Type DRUG

Placebo for warfarin

tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

Intervention Type DRUG

apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Intervention Type DRUG

Other Intervention Names

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Coumadin BMS-565793 BMS-562247

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥ 18 years of age
* Clinical diagnosis of DVT or PE

Exclusion Criteria

* Contraindications for enoxaparin or warfarin
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Alabama Clinical Therapeutics, Llc

Birmingham, Alabama, United States

Site Status

Horizon Research Group, Inc.

Mobile, Alabama, United States

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Fort Smith Lung Center

Fort Smith, Arkansas, United States

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University Of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

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Beaver Medical Group

Banning, California, United States

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University Of California San Francisco-Fresno

Fresno, California, United States

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University Of California, Davis Medical Center

Sacramento, California, United States

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Chest Medicine & Critical Care Medical Gr. Inc.

San Diego, California, United States

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Stanford University Medical Center

Stanford, California, United States

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Harbor Ucla Medical Center

Torrance, California, United States

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New West Physicians

Golden, Colorado, United States

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Drogue Medical, Llc

Wheat Ridge, Colorado, United States

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Bridgeport Hospital

Bridgeport, Connecticut, United States

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Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

New Haven, Connecticut, United States

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George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

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Bay Pines Va Healthcare Systems

Bay Pines, Florida, United States

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Daniel G. Lorch, Jr, Md, Cpi

Brandon, Florida, United States

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Research Alliance, Inc.

Clearwater, Florida, United States

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River City Clinical Research

Jacksonville, Florida, United States

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Pasadena Center For Medical Research

St. Petersburg, Florida, United States

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Tampa Clinical Research

Tampa, Florida, United States

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Office Of Michele S. Maholtz Md

Vero Beach, Florida, United States

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Cleveland Clinic Florida

Weston, Florida, United States

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Atlanta Pulmonary Group

Atlanta, Georgia, United States

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Atlanta Institute For Medical Research, Inc

Decatur, Georgia, United States

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Chatham Hospitalists

Savannah, Georgia, United States

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Gateway Cardiology. P.C

Jerseyville, Illinois, United States

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West Suburban Medical Center

Oak Park, Illinois, United States

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Infectious Disease Of Indiana Psc

Carmel, Indiana, United States

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Heartland Vascular Medicine And Surgery

Windsor Heights, Iowa, United States

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Kentucky Lung Clinic

Hazard, Kentucky, United States

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Univ. Of Kentucky Dept. Of Surgery

Lexington, Kentucky, United States

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Research Integrity, Llc

Owensboro, Kentucky, United States

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Pen Bay Medical Center

Rockport, Maine, United States

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Anne Arundel Medical Center

Annapolis, Maryland, United States

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R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

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Medstar Research Health Institute

Baltimore, Maryland, United States

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Henry Ford Hospital

Detroit, Michigan, United States

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Hurley Medical Center

Flint, Michigan, United States

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Mississippi Medical Research, Llc

Picayune, Mississippi, United States

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University Of Missouri-Columbia

Columbia, Missouri, United States

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Veterans Affairs Medical Center

Kansas City, Missouri, United States

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Washington University School Of Medicine

St Louis, Missouri, United States

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St. John'S Mercy Medical Center

St Louis, Missouri, United States

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Mercury Street Medical Group, Pllc

Butte, Montana, United States

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Great Falls Clinic, Llp

Great Falls, Montana, United States

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Internal Medical Associates Of Grand Island, P.C

Grand Island, Nebraska, United States

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Creighton University Medical Center

Omaha, Nebraska, United States

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Morristown Memorial Hospital

Morristown, New Jersey, United States

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Pulmonary & Critical Care Services, Pc

Albany, New York, United States

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Kaleida Health System

Buffalo, New York, United States

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Richmond University Medical Center

Staten Island, New York, United States

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New York Medical College

Valhalla, New York, United States

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Carolinas Medical Center

Charlotte, North Carolina, United States

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Duke University Medical Center

Durham, North Carolina, United States

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Rex Healthcare

Raleigh, North Carolina, United States

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Piedmont Healthcare/Research

Statesville, North Carolina, United States

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Wilmington Medical Research

Wilmington, North Carolina, United States

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Clinical Trials Of America, Inc.

Winston-Salem, North Carolina, United States

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Altru Health System Clinic

Grand Forks, North Dakota, United States

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Huron Hospital

Cleveland, Ohio, United States

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Remington Davis Inc.

Columbus, Ohio, United States

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Oregon Health Science University

Portland, Oregon, United States

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

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Greenville Hospital System

Greenville, South Carolina, United States

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Palmetto Clinical Research

Summerville, South Carolina, United States

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Holston Medical Group

Bristol, Tennessee, United States

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Kore Cv Research

Jackson, Tennessee, United States

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Primecare Medical Group

Houston, Texas, United States

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Cancer Care Centers Of South Texas

San Antonio, Texas, United States

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University Of Utah Medical Center

Salt Lake City, Utah, United States

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Lake Washington Vascular, Pllc

Bellevue, Washington, United States

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Franciscan Research Center

Tacoma, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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Corrientes, Corrientes Province, Argentina

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Garran, Australian Capital Territory, Australia

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Concord, New South Wales, Australia

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Lismore, New South Wales, Australia

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Adelaide, South Australia, Australia

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Bedford Park, South Australia, Australia

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Hobart, Tasmania, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Ringwood East, Victoria, Australia

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Windsor, Victoria, Australia

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Perth, Western Australia, Australia

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Graz, , Austria

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Belo Horizonte - Mg, Minas Gerais, Brazil

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Edmonton, Alberta, Canada

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Saint John, New Brunswick, Canada

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Montreal, Quebec, Canada

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Punta Arenas, Magallanes Antartica, Chile

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Viña del Mar, Región de Valparaíso, Chile

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Independencia, Santiago Metropolitan, Chile

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Beijing, Beijing Municipality, China

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Xi'an, , China

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Arhus C, , Denmark

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Hellerup, , Denmark

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Herning, , Denmark

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Hilleroed, , Denmark

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Horsens, , Denmark

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Næstved, , Denmark

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Silkeborg, , Denmark

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Angers, , France

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Le Kremlin-Bicêtre, , France

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Nantes, , France

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Saint-Priest-en-Jarez, , France

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Toulouse, , France

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Vernon, , France

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Mannheim, , Germany

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Munich, , Germany

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München, , Germany

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Pokfulman, , Hong Kong

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Shatin, N.T, , Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Gyula, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Székesfehérvár, , Hungary

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Zalaegerszeg, , Hungary

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Manipal, Karnataka, India

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Pune, Maharashtra, India

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Mohali, Punjab, India

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Ludhiana, Tagore Nagar, India

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Chennai, Tamil Nadu, India

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Bangalore, , India

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Pune, , India

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Tiberias, Lower Galillee, Israel

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Afula, , Israel

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Ashkelon, , Israel

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Hadera, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Nahariya, , Israel

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Rehovot, , Israel

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Bologna, , Italy

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Ipoh, Perak, Malaysia

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George Town, Pulau Pinang, Malaysia

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Aguascalientes, Aguascalientes, Mexico

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Durango, Durango, Mexico

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Tijuana, Estado de Baja California, Mexico

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Xalapa, Veracruz, Mexico

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Ålesund, , Norway

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Fredrikstad, , Norway

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Gjettum, , Norway

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Gjøvik, , Norway

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Hamar, , Norway

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Trondheim, , Norway

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Bialystok, , Poland

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Wroclaw, , Poland

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Coimbra, , Portugal

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Guarda, , Portugal

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Lisbon, , Portugal

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San Juan, , Puerto Rico

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Baia Mare, , Romania

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Bucharest, , Romania

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Târgu Mureş, , Romania

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Moscow, , Russia

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Yaroslavl, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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George, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Busan, , South Korea

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Torrevieja, Alicante, Spain

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Getafe, , Spain

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Málaga, , Spain

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Chernihiv, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

Site Status

Local Institution

Kharkiv, , Ukraine

Site Status

Local Institution

Kyiv, , Ukraine

Site Status

Local Institution

Lviv, , Ukraine

Site Status

Local Institution

Odesa, , Ukraine

Site Status

Local Institution

Ternopil, , Ukraine

Site Status

Local Institution

Vinnytsia, , Ukraine

Site Status

Local Institution

Zaporizhzhia, , Ukraine

Site Status

Local Institution

Livingston, West Lothian, United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Brazil Canada Chile China Czechia Denmark France Germany Hong Kong Hungary India Israel Italy Malaysia Mexico Norway Poland Portugal Puerto Rico Romania Russia Singapore South Africa South Korea Spain Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35570249 (View on PubMed)

Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.

Reference Type DERIVED
PMID: 33890242 (View on PubMed)

Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.

Reference Type DERIVED
PMID: 30650446 (View on PubMed)

Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.

Reference Type DERIVED
PMID: 26627879 (View on PubMed)

Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

Reference Type DERIVED
PMID: 23808982 (View on PubMed)

Related Links

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Other Identifiers

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EUDRACT: 2007-007867-25

Identifier Type: -

Identifier Source: secondary_id

CV185-056

Identifier Type: -

Identifier Source: org_study_id

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