Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

NCT ID: NCT00986154

Last Updated: 2019-03-05

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

8292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-04-30

Brief Summary

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Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Detailed Description

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Conditions

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Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Thromboembolism Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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heparin/edoxaban tosylate

Group Type EXPERIMENTAL

edoxaban tosylate(DU-176b)

Intervention Type DRUG

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

low molecular weight heparin/unfractionated heparin

Intervention Type DRUG

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

heparin/warfarin

Group Type ACTIVE_COMPARATOR

low molecular weight heparin/unfractionated heparin

Intervention Type DRUG

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

warfarin

Intervention Type DRUG

tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Interventions

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edoxaban tosylate(DU-176b)

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

Intervention Type DRUG

low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

Intervention Type DRUG

warfarin

tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects older than the minimum legal adult age (country specific);
* Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
* Able to provide written informed consent

Exclusion Criteria

* thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
* More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
* Calculated Creatinine clearance (CrCL) \< 30 mL/min;
* significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
* patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
* active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
* chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
* treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
* concurrent treatment with potent P-gp inhibitors;
* subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site 7103

Mobile, Alabama, United States

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Investigational Site 7132

Montgomery, Alabama, United States

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Investigational Site 7126

Phoenix, Arizona, United States

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Investigational Site 7139

Little Rock, Arkansas, United States

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Investigational Site 1070

Anaheim, California, United States

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Investigational Site 7125

Los Alamitos, California, United States

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Investigational Site 1093

Monterey, California, United States

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Investigational Site 1069

Palm Springs, California, United States

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Investigational Site 7150

San Diego, California, United States

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Investigational Site 1089

Vista, California, United States

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Investigational Site 1012

Aurora, Colorado, United States

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Investigational Site 1013

Boulder, Colorado, United States

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Investigational Site 1017

Denver, Colorado, United States

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Investigational Site 1018

Lakewood, Colorado, United States

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Investigational Site 1019

Littleton, Colorado, United States

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Investigational Site 1022

Thornton, Colorado, United States

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Investigational Site 1023

Thornton, Colorado, United States

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Brandon, Florida, United States

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Investigational Site 1071

Clearwater, Florida, United States

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Investigational Site 7117

Fort Myers, Florida, United States

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Investigational Site 7106

Gainesville, Florida, United States

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Investigational Site 1005

Ocoee, Florida, United States

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Investigational Site 1006

Orlando, Florida, United States

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Investigational Site 7144

Sarasota, Florida, United States

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Investigational Site 7127

St. Petersburg, Florida, United States

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Investigational Site 1007

Winter Park, Florida, United States

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Investigational Site 7104

Albany, Georgia, United States

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Investigational Site 1095

Columbus, Georgia, United States

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Investigational Site 1080

Jonesboro, Georgia, United States

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Investigational Site 7146

Savannah, Georgia, United States

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Investigational Site 1098

Park Ridge, Illinois, United States

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Carmel, Indiana, United States

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Investigational Site 7115

Paducah, Kentucky, United States

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Investigational Site 1065

Covington, Louisiana, United States

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Investigational Site 1068

Baltimore, Maryland, United States

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Investigational Site 1037

Westminster, Maryland, United States

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Investigational Site 1038

Westminster, Maryland, United States

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Investigational Site 7133

Kansas City, Missouri, United States

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Investigational Site 7147

Butte, Montana, United States

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Investigational Site 1039

Las Vegas, Nevada, United States

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Investigational Site 7143

Rochester, New York, United States

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Investigational Site 7135

Durham, North Carolina, United States

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Investigational Site 7145

Statesville, North Carolina, United States

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Investigational Site 7138

Maumee, Ohio, United States

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Investigational Site 7122

Toledo, Ohio, United States

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Investigational Site 7152

Bend, Oregon, United States

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Portland, Oregon, United States

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Investigational Site 1004

Camp Hill, Pennsylvania, United States

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Investigational Site 7109

Ephrata, Pennsylvania, United States

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Investigational Site 1049

Kingston, Pennsylvania, United States

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Investigational Site 7109

Lancaster, Pennsylvania, United States

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Investigational Site 7154

Sellersville, Pennsylvania, United States

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Investigational Site 7128

Uniontown, Pennsylvania, United States

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Investigational Site 1031

Easley, South Carolina, United States

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Investigational Site 1032

Greenville, South Carolina, United States

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Investigational Site 1034

Greenville, South Carolina, United States

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Investigational Site 1033

Greenville, South Carolina, United States

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Investigational Site 1035

Seneca, South Carolina, United States

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Investigational Site 1036

Spartanburg, South Carolina, United States

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Investigational Site 1009

Arlington, Texas, United States

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Investigational Site 1050

Dallas, Texas, United States

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Investigational Site 1047

Fort Worth, Texas, United States

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Investigational Site 7105

Fort Worth, Texas, United States

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Investigational Site 1048

Fort Worth, Texas, United States

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Investigational Site 1059

Midland, Texas, United States

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Investigational Site 1040

New Braunfels, Texas, United States

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Investigational Site 1041

Odessa, Texas, United States

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Investigational Site 1002

San Antonio, Texas, United States

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Investigational Site 1058

Sugar Land, Texas, United States

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Tyler, Texas, United States

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Investigational Site 1008

Waco, Texas, United States

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Investigational Site 7123

Salt Lake City, Utah, United States

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Investigational Site 1003

Fredericksburg, Virginia, United States

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Investigational Site 1025

Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Randallstown, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Vancouver, Washington, United States

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Investigational Site 1057

Vancouver, Washington, United States

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Investigational Site 1100

Buenos Aires, , Argentina

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Investigational Site 1103

Buenos Aires, , Argentina

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Investigational Site 1106

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Investigational Site 1110

Pcia de Corrientes, , Argentina

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Investigational Site 1109

Santa Fe, , Argentina

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Investigational Site 4205

Bedford Park, , Australia

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Investigational Site 4209

Box Hill, , Australia

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Investigational Site 4210

Clayton, , Australia

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Fremantle, , Australia

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Garran, , Australia

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Kogarah, , Australia

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Investigational Site 4207

Perth, , Australia

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Investigational Site 4203

Redcliffe, , Australia

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Investigational Site 4206

Saint Leonards NSW, , Australia

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Investigational Site 4214

South Brisbane, , Australia

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Investigational Site 4212

Westmead NSW, , Australia

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Investigational Site 4200

Windsor, , Australia

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Investigational Site 2802

Feldkirch, , Austria

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Graz, , Austria

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Investigational Site 2800

Innsbruck, , Austria

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Investigational Site 2804

Linz, , Austria

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Sr. M. Restitutagasse, , Austria

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Vienna, , Austria

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Investigational Site 2704

Grodno, , Belarus

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Investigational Site 2703

Homyel, , Belarus

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Minsk, , Belarus

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Minsk, , Belarus

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Minsk, , Belarus

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Investigational Site 2705

Mogilev, , Belarus

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Investigational Site 1608

Aalst, , Belgium

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Lier, , Belgium

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Belo Horizonte, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Investigational Site 2903

Curitiba, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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São Bernardo do Campo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Investigational Site 2006

Edmonton, Alberta, Canada

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Investigational Site 2001

London, Ontario, Canada

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Investigational Site 2007

Newmarket, Ontario, Canada

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Investigational Site 2000

Ottawa, Ontario, Canada

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Investigational Site 2003

Richmond Hill, Ontario, Canada

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Investigational Site 2005

Halifax, , Canada

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Investigational Site 2004

Montreal, , Canada

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Investigational Site 1200

Santiago, , Chile

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Investigational Site 1204

Santiago, , Chile

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Investigational Site 4301

Beijing, , China

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Beijing, , China

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Investigational Site 4306

Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Guangzhou, , China

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Hangzhou, , China

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Hebei Province, , China

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Jiangsu, , China

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Investigational Site 4317

Kunming, , China

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Investigational Site 4328

Nanjing, , China

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Investigational Site 4319

Nanning, , China

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Investigational Site 4313

Qingdao, , China

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Investigational Site 4303

Shanghai, , China

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Investigational Site 4324

Shanghai, , China

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Investigational Site 4330

Shanghai, , China

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Investigational Site 4335

Shanghai, , China

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Investigational Site 4326

Shenyang, , China

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Investigational Site 4308

Sichuan Province, , China

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Investigational Site 4318

Taiyuan, , China

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Investigational Site 4320

Tianjin, , China

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Investigational site 4338

Xi'an, , China

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Investigational Site 4315

Yinchuan, , China

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Chodov, , Czechia

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Jihlava, , Czechia

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Investigational Site 1902

Liberec, , Czechia

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Investigational Site 1908

Olomouc, , Czechia

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Investigational Site 1905

Ostrava, , Czechia

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Investigational Site 1901

Pilsen, , Czechia

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Investigational Site 1910

Pilsen, , Czechia

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Investigational Site 1904

Prague, , Czechia

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Ústí nad Labem, , Czechia

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Investigational Site 6010

Aarhus, , Denmark

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Arhus N., , Denmark

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Copenhagen, , Denmark

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Investigational Site 6003

Herlev, , Denmark

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Ringvej, , Denmark

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Investigational Site 6001

Svendborg, , Denmark

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Investigational Site 2100

Tallinn, , Estonia

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Investigational Site 2101

Tallinn, , Estonia

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Investigational Site 2102

Tartu, , Estonia

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Investigational Site 3314

Agen, , France

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Investigational Site 3302

Amiens, , France

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Investigational Site 3311

Angers, , France

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Investigational Site 3321

Annecy, , France

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Investigational Site 3300

Arras, , France

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Investigational Site 3301

Besançon, , France

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Investigational Site 3329

Bordeaux, , France

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Investigational Site 3310

Brest, , France

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Investigational Site 3333

Cannes, , France

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Investigational Site 3327

Colombes, , France

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Investigational Site 3323

Dijon, , France

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Investigational Site 3307

Grenoble, , France

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Investigational Site 3322

Grenoble, , France

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Investigational Site 3325

Hetztessy, , France

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Investigational Site 3328

Le Mans, , France

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Investigational Site 3339

Lille, , France

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Lormont, , France

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Investigational Site 3318

Lyon, , France

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Investigational Site 3303

Montpellier, , France

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Nantes, , France

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Investigational Site 3319

Nice, , France

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Investigational Site 3308

Paris, , France

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Investigational Site 3312

Paris, , France

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Investigational Site 3313

Paris, , France

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Investigational Site 3337

Paris, , France

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Investigational Site 3335

Pessac, , France

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Investigational Site 3341

Pessac, , France

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Investigational Site 3336

Pierre-Bénite, , France

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Roskilde, , France

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Saint Aubin Surscie, , France

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Investigational Site 3305

Saint-Etienne, , France

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Investigational Site 3316

Toulon, , France

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Investigational Site 1718

Berlin, , Germany

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Investigational Site 1720

Bielefeld, , Germany

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Investigational Site 1715

Bruchsal, , Germany

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Investigational Site 1700

Darmstadt, , Germany

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Investigational Site 1719

Dortmund, , Germany

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Investigational Site 1701

Dresden, , Germany

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Investigational Site 1707

Dresden, , Germany

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Investigational Site 1721

Hamburg, , Germany

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Magdeburg, , Germany

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Investigational Site 1712

Mainz, , Germany

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Investigational Site 1704

München, , Germany

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Investigational Site 1714

Nordhausen, , Germany

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Investigational Site 1711

Paderborn, , Germany

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Investigational Site 1706

Tübingen, , Germany

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Investigational Site 1708

Witten, , Germany

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Investigational Site 5413

Baja, , Hungary

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Investigational Site 5401

Budapest, , Hungary

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Investigational Site 5404

Budapest, , Hungary

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Investigational Site 5409

Budapest, , Hungary

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Investigational Site 5414

Budapest, , Hungary

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Investigational Site 5400

Debrecen, , Hungary

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Investigational Site 5402

Kecskemét, , Hungary

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Investigational Site 5405

Kistarcsa, , Hungary

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Maglodi, , Hungary

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Investigational Site 5407

Miskolc, , Hungary

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Investigational Site 5410

Pécs, , Hungary

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Rakoczi, , Hungary

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Investigational Site 5403

Szentes, , Hungary

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Investigational Site 5408

Szombathely, , Hungary

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Investigational Site 5412

Zalaegerszeg, , Hungary

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Zrinyi, , Hungary

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Ahmedabad, , India

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Andhra Pradesh, , India

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Investigational Site 4402

Bangalore, , India

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Investigational Site 4405

Bangalore, , India

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Investigational Site 4442

Bangalore, , India

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Investigational Site 4459

Bangalore, , India

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Investigational Site 4460

Bangalore, , India

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Investigational Site 4472

Bangalore, , India

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Gujarat, , India

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Gurgaon, , India

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Haryāna, , India

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Investigational Site 5514

Holon, , India

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Investigational Site 4407

Hyderabad, , India

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Investigational Site 4430

Hyderabad, , India

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Hyderabad, , India

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Hyderabad, , India

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Karnataka, , India

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Kerala, , India

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Investigational Site 4420

Lucknow, , India

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Madhya Pradesh, , India

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Maharashtra, , India

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Investigational Site 4409

Mumbai, , India

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Investigational Site 4424

Mumbai, , India

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Investigational Site 4419

New Delhi, , India

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Investigational Site 4428

New Delhi, , India

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Investigational Site 4441

New Delhi, , India

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Investigational Site 4425

Pune, , India

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Investigational Site 4438

Pune, , India

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Investigational Site 4443

Pune, , India

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Investigational Site 4462

Pune, , India

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Punjab, , India

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Rajasthan, , India

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Investigational Site 4470

Secunderbad, , India

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Tamil Nadu, , India

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Uttar Pradesh, , India

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Vadodara, , India

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Visakhapatnam, , India

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Afula, , Israel

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Ashkelon, , Israel

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Hadera, , Israel

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Investigational Site 5506

Haifa, , Israel

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Investigational Site 5508

Haifa, , Israel

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Investigational Site 5500

Holon, , Israel

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Investigational Site 5501

Jerusalem, , Israel

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Investigational Site 5505

Kfar Saba, , Israel

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Investigational Site 5513

Nahariya, , Israel

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Investigational Site 5510

Petah Tikva, , Israel

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Investigational Site 5512

Poria – Neve Oved, , Israel

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Investigational Site 5503

Tel Aviv, , Israel

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Investigational Site 5509

Tel Litwinsky, , Israel

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Investigational Site 3508

Bergamo, , Italy

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Investigational Site 3506

Chieti, , Italy

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Investigational Site 3500

Emilia, , Italy

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Investigational Site 3504

Milan, , Italy

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Padua, , Italy

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Investigational Site 3502

Palermo, , Italy

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Investigational Site 3507

Parma, , Italy

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Investigational Site 3501

Pavia, , Italy

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Investigational Site 3505

Rozzano, , Italy

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Investigational Site 3510

Udine, , Italy

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Investigational Site 3503

Varese, , Italy

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Investigational Site 3509

Venezia, , Italy

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Investigational Site 6137

Aichi, , Japan

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Investigational Site 6104

Aomori, , Japan

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Investigational Site 6117

Chiba, , Japan

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Investigational Site 6119

Fukuoka, , Japan

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Fukuoka, , Japan

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Investigational Site 6110

Fukushima, , Japan

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Investigational Site 6150

Hiroshima, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Investigational Site 6114

Ishikawa, , Japan

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Kagoshima, , Japan

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Investigational Site 6112

Kanagawa, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Investigational Site 6129

Mie, , Japan

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Investigational Site 6146

Nagano, , Japan

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Investigational Site 6139

Nagasaki, , Japan

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Investigational Site 6107

Niigata, , Japan

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Investigational Site 6152

Okayama, , Japan

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Okinawa, , Japan

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Investigational Site 6132

Osaka, , Japan

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Investigational Site 6130

Sapporo, , Japan

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Investigational Site 6143

Shizuoka, , Japan

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Investigational Site 6102

Tokyo, , Japan

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Investigational Site 6105

Tokyo, , Japan

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Investigational Site 6113

Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tottori, , Japan

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Investigational Site 1303

Zapopan, Jalisco, Mexico

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Investigational Site 1302

Monterrey, Nuevo León, Mexico

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Investigational Site 1311

Col. Lomas Altas C.P, , Mexico

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Investigational Site 1304

Guadalajara, , Mexico

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Investigational Site 1312

Guadalajara, , Mexico

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Investigational Site 1300

Hermosillo, , Mexico

Site Status

Investigational Site 1305

Monterrey, Nuevo Leon, , Mexico

Site Status

Investigational Site 1308

San Luis Potosí City, , Mexico

Site Status

Investigational Site 1301

Yucatán, , Mexico

Site Status

Investigational Site 3608

Alkmaar, , Netherlands

Site Status

Investigational Site 3607

Almere Stad, , Netherlands

Site Status

Investigational Site 3617

Amersfoort, , Netherlands

Site Status

Investigational Site 3611

Amsterdam, , Netherlands

Site Status

Investigational Site 3609

Assen, , Netherlands

Site Status

Investigational Site 3603

Groningen, , Netherlands

Site Status

Investigational Site 3612

Heerlen, , Netherlands

Site Status

Investigational Site 3613

Hoofddorp, , Netherlands

Site Status

Investigational Site 3602

Nijmegen, , Netherlands

Site Status

Investigational Site 3615

Rotterdam, , Netherlands

Site Status

Investigational Site 4702

Auckland, , New Zealand

Site Status

Investigational Site 4703

Auckland, , New Zealand

Site Status

Investigational Site 4700

Christchurch, , New Zealand

Site Status

Investigational Site 4704

Wellington, , New Zealand

Site Status

Investigational Site 3701

Fredrikstad, , Norway

Site Status

Investigational Site 3700

Oslo, , Norway

Site Status

Pasig, , Philippines

Site Status

Investigational Site 4800

Quezon City, , Philippines

Site Status

Investigational site 4801

Quezon City, , Philippines

Site Status

Investigational Site 4802

Quezon City, , Philippines

Site Status

Investigational Site 5015

Bialystok, , Poland

Site Status

Investigational Site 5005

Krakow, , Poland

Site Status

Investigational Site 5019

Olsztyn, , Poland

Site Status

Investigational Site 5018

Tarnów, , Poland

Site Status

Investigational Site 5003

Warsaw, , Poland

Site Status

Investigational Site 5007

Warsaw, , Poland

Site Status

Investigational Site 5008

Warsaw, , Poland

Site Status

Investigational Site 5014

Warsaw, , Poland

Site Status

Barnaul, , Russia

Site Status

Investigational Site 3023

Chelyabinsk, , Russia

Site Status

Investigational Site 3017

Irkutsk, , Russia

Site Status

Investigational Site 3019

Kemerovo, , Russia

Site Status

Investigational Site 3020

Krasnoyarsk, , Russia

Site Status

Investigational Site 3030

Krasnoyarsk, , Russia

Site Status

Investigational Site 3029

Moscow, , Russia

Site Status

Investigational Site 3028

Novosibirsk, , Russia

Site Status

Investigational Site 3009

Omsk, , Russia

Site Status

Investigational Site 3022

Ryazan, , Russia

Site Status

Investigational Site 3000

Saint Petersburg, , Russia

Site Status

Investigational Site 3003

Saint Petersburg, , Russia

Site Status

Investigational Site 3027

Saint Petersburg, , Russia

Site Status

Saratov, , Russia

Site Status

Investigational Site 3024

Sochi, , Russia

Site Status

Investigational Site 3025

Tyumen, , Russia

Site Status

Investigational Site 3016

Ufa, , Russia

Site Status

Investigational Site 3004

Yaroslavl, , Russia

Site Status

Investigational Site 3010

Yaroslavl, , Russia

Site Status

Investigational Site 5900

Outram Road, , Singapore

Site Status

Investigational Site 5902

Singapore, , Singapore

Site Status

Investigational Site 4912

Cape Town, , South Africa

Site Status

Investigational Site 4907

Centurion, , South Africa

Site Status

Investigational Site 4901

Johannesburg, , South Africa

Site Status

Investigational Site 4905

Johannesburg, , South Africa

Site Status

Investigational Site 4909

Johannesburg, , South Africa

Site Status

Investigational Site 4910

Johannesburg, , South Africa

Site Status

Investigational Site 4908

Lyttleton, , South Africa

Site Status

Investigational Site 4903

Pretoria, , South Africa

Site Status

Investigational Site 4906

Pretoria, , South Africa

Site Status

Investigational Site 4904

Somerset West, , South Africa

Site Status

Investigational Site 4900

Worcester, , South Africa

Site Status

Investigational Site 4513

Busan, , South Korea

Site Status

Investigational Site 4509

Daegu, , South Korea

Site Status

Investigational Site 4501

Gyeonggi-do, , South Korea

Site Status

Investigational Site 4506

Seoul, , South Korea

Site Status

Investigational Site 4507

Seoul, , South Korea

Site Status

Investigational Site 4508

Seoul, , South Korea

Site Status

Investigational Site 4515

Seoul, , South Korea

Site Status

Investigational site 1503

Barcelona, , Spain

Site Status

Investigational Site 1502

Cabra, , Spain

Site Status

Investigational Site 3900

Hällingsjö, , Sweden

Site Status

Investigational Site 3904

Kristianstad, , Sweden

Site Status

Investigational Site 3903

Stockholm, , Sweden

Site Status

Investigational Site 3905

Stockholm, , Sweden

Site Status

Investigational Site 3902

Sundsvall, , Sweden

Site Status

Investigational Site 4103

Aarau, , Switzerland

Site Status

Investigational Site 4110

Basel, , Switzerland

Site Status

Investigational Site 4104

Bellinzona, , Switzerland

Site Status

Investigational Site 4102

Chur, , Switzerland

Site Status

Investigational Site 4109

Lausanne, , Switzerland

Site Status

Investigational Site 4100

Lucerne, , Switzerland

Site Status

Hualien City, , Taiwan

Site Status

Investigational Site 5104

Kaohsiung City, , Taiwan

Site Status

Investigational Site 5105

Taichung, , Taiwan

Site Status

Investigational Site 5101

Taipei, , Taiwan

Site Status

Investigational Site 5103

Taipei, , Taiwan

Site Status

Investigational Site 5200

Bangkok, , Thailand

Site Status

Investigational Site 5202

Bangkok, , Thailand

Site Status

Investigational Site 5203

Nakhorn Nayok, , Thailand

Site Status

Investigational Site 5702

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site 5703

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site 5702

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site 5706

Istanbul, , Turkey (Türkiye)

Site Status

Chernihiv, , Ukraine

Site Status

Investigational Site 4008

Dnipropetrovsk, , Ukraine

Site Status

Investigational Site 4010

Donetsk, , Ukraine

Site Status

Investigational Site 4000

Ivano-Frankivsk, , Ukraine

Site Status

Investigational Site 4002

Kharkiv, , Ukraine

Site Status

Investigational Site 4001

Kiev, , Ukraine

Site Status

Investigational Site 4007

Ternopil, , Ukraine

Site Status

Investigational Site 4009

Uzhhorod, , Ukraine

Site Status

Investigational Site 4003

Vinnitsya, , Ukraine

Site Status

Investigational Site 4006

Zaporizhzhia, , Ukraine

Site Status

Investigational Site 7005

Coventry, , United Kingdom

Site Status

Investigational Site 7006

Hull, , United Kingdom

Site Status

Investigational Site 7000

London, , United Kingdom

Site Status

Investigational Site 7003

London, , United Kingdom

Site Status

Investigational Site 7004

London, , United Kingdom

Site Status

Investigational Site 7001

Newcastle, , United Kingdom

Site Status

Investigational Site 7007

Plymouth, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belarus Belgium Brazil Canada Chile China Czechia Denmark Estonia France Germany Hungary India Israel Italy Japan Mexico Netherlands New Zealand Norway Philippines Poland Russia Singapore South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.

Reference Type DERIVED
PMID: 29248859 (View on PubMed)

Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.

Reference Type DERIVED
PMID: 28689179 (View on PubMed)

Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.

Reference Type DERIVED
PMID: 27570090 (View on PubMed)

Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.

Reference Type DERIVED
PMID: 27476789 (View on PubMed)

Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.

Reference Type DERIVED
PMID: 26179767 (View on PubMed)

Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.

Reference Type DERIVED
PMID: 23991658 (View on PubMed)

Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.

Reference Type DERIVED
PMID: 21861537 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

The Edoxaban Hokusai VTE Study

Identifier Type: -

Identifier Source: secondary_id

DU176b-D-U305

Identifier Type: -

Identifier Source: org_study_id

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