AzTrials
AzTrials

Venous ThromboembolismPhase 3NCT00986154

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).

A Phase 3 study testing edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin and warfarin in people with Venous Thromboembolism and Deep Vein Thrombosis (DVT), run by Daiichi Sankyo at 454 sites in 38 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin and warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,292 participants
Where
454 sitesin 38 countries
Study dates
Oct 2009to Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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

Trial locations and contacts

454 sites in 38 countries.

454 sites in 38 countries

United States82 sites

  • Investigational Site 7104

    Albany, Georgia, 31701

  • Investigational Site 1070

    Anaheim, California, 92801

  • Investigational Site 1009

    Arlington, Texas, 76014-2084

  • Investigational Site 1012

    Aurora, Colorado, 80012

  • Investigational Site 1068

    Baltimore, Maryland, 21215

  • Investigational Site 7152

    Bend, Oregon, 97701

  • Investigational Site 1013

    Boulder, Colorado, 80303

  • Study site

    Brandon, Florida

  • Investigational Site 7147

    Butte, Montana, 59701

  • Investigational Site 1004

    Camp Hill, Pennsylvania, 17011

  • Study site

    Carmel, Indiana

  • Investigational Site 1071

    Clearwater, Florida, 33756

  • Investigational Site 1095

    Columbus, Georgia, 31904

  • Investigational Site 1065

    Covington, Louisiana, 70433

  • Investigational Site 1050

    Dallas, Texas

  • Investigational Site 1017

    Denver, Colorado, 80218

  • Investigational Site 7135

    Durham, North Carolina, 27710

  • Investigational Site 1031

    Easley, South Carolina, 29640

  • Investigational Site 7109

    Ephrata, Pennsylvania, 17522

  • Investigational Site 7117

    Fort Myers, Florida, 33907

  • Investigational Site 1047

    Fort Worth, Texas, 76104

  • Investigational Site 7105

    Fort Worth, Texas, 76109

  • Investigational Site 1048

    Fort Worth, Texas, 76132

  • Investigational Site 1003

    Fredericksburg, Virginia

  • Investigational Site 7106

    Gainesville, Florida, 32605

  • Investigational Site 1032

    Greenville, South Carolina, 29605

  • Investigational Site 1034

    Greenville, South Carolina, 29605

  • Investigational Site 1033

    Greenville, South Carolina, 29615

  • Investigational Site 1080

    Jonesboro, Georgia, 30236

  • Investigational Site 7133

    Kansas City, Missouri, 64128

  • Investigational Site 1049

    Kingston, Pennsylvania, 18704

  • Investigational Site 1018

    Lakewood, Colorado, 80228

  • Investigational Site 7109

    Lancaster, Pennsylvania, 17602

  • Investigational Site 1039

    Las Vegas, Nevada, 89169

  • Investigational Site 7139

    Little Rock, Arkansas, 72205

  • Investigational Site 1019

    Littleton, Colorado, 80120-4413

  • Investigational Site 7125

    Los Alamitos, California, 90720

  • Investigational Site 7138

    Maumee, Ohio, 43537

  • Investigational Site 1059

    Midland, Texas

  • Investigational Site 7103

    Mobile, Alabama, 36608

  • Investigational Site 1093

    Monterey, California, 93940

  • Investigational Site 7132

    Montgomery, Alabama, 36116

  • Investigational Site 1040

    New Braunfels, Texas, 78130

  • Investigational Site 1025

    Newport News, Virginia

  • Investigational Site 1024

    Norfolk, Virginia

  • Investigational Site 1005

    Ocoee, Florida, 34761

  • Investigational Site 1041

    Odessa, Texas

  • Investigational Site 1006

    Orlando, Florida, 32806

  • Investigational Site 7115

    Paducah, Kentucky, 42003

  • Investigational Site 1069

    Palm Springs, California, 92262

  • Investigational Site 1098

    Park Ridge, Illinois, 60068

  • Investigational Site 7126

    Phoenix, Arizona, 85006

  • Study site

    Portland, Oregon

  • Investigational Site 1066

    Randallstown, Virginia

  • Investigational Site 7143

    Rochester, New York, 14642

  • Investigational Site 7123

    Salt Lake City, Utah

  • Investigational Site 1002

    San Antonio, Texas, 78229

  • Investigational Site 7150

    San Diego, California, 92123

  • Investigational Site 7144

    Sarasota, Florida, 34232

  • Investigational Site 7146

    Savannah, Georgia, 31419

  • Investigational Site 7120

    Seattle, Washington

  • Investigational Site 7154

    Sellersville, Pennsylvania

  • Investigational Site 1035

    Seneca, South Carolina, 29672

  • Investigational Site 1036

    Spartanburg, South Carolina, 29307

  • Investigational Site 7127

    St. Petersburg, Florida, 33707

  • Investigational Site 7145

    Statesville, North Carolina, 28625

  • Investigational Site 1058

    Sugar Land, Texas

  • Investigational Site 1076

    Tacoma, Washington

  • Investigational Site 1022

    Thornton, Colorado, 80260

  • Investigational Site 1023

    Thornton, Colorado, 80260

  • Investigational Site 7122

    Toledo, Ohio, 43606

  • Investigational Site 1042

    Tyler, Texas

  • Investigational Site 7128

    Uniontown, Pennsylvania

  • Investigational Site 1053

    Vancouver, Washington

  • Investigational Site 1056

    Vancouver, Washington

  • Investigational Site 1057

    Vancouver, Washington

  • Investigational Site 1030

    Virginia Beach, Virginia

  • Investigational Site 1089

    Vista, California, 92083

  • Investigational Site 1008

    Waco, Texas

  • Investigational Site 1037

    Westminster, Maryland, 21157

  • Investigational Site 1038

    Westminster, Maryland, 21157

  • Investigational Site 1007

    Winter Park, Florida, 32789

Other trials in United States

India37 sites

  • Study site

    Ahmedabad

  • Study site

    Andhra Pradesh

  • Investigational Site 4402

    Bangalore

  • Investigational Site 4405

    Bangalore

  • Investigational Site 4442

    Bangalore

  • Investigational Site 4459

    Bangalore

  • Investigational Site 4460

    Bangalore

  • Investigational Site 4472

    Bangalore

  • Study site

    Gujarat

  • Study site

    Gūrgaon

  • Study site

    Haryāna

  • Investigational Site 5514

    Holon

  • Investigational Site 4407

    Hyderabad

  • Investigational Site 4430

    Hyderabad

  • Investigational Site 4444

    Hyderabad

  • Investigational Site 4451

    Hyderabad

  • Study site

    Karnataka

  • Study site

    Kerala

  • Investigational Site 4420

    Lucknow

  • Study site

    Madhya Pradesh

  • Study site

    Maharashtra

  • Investigational Site 4409

    Mumbai

  • Investigational Site 4424

    Mumbai

  • Investigational Site 4419

    New Delhi

  • Investigational Site 4428

    New Delhi

  • Investigational Site 4441

    New Delhi

  • Investigational Site 4425

    Pune

  • Investigational Site 4438

    Pune

  • Investigational Site 4443

    Pune

  • Investigational Site 4462

    Pune

  • Study site

    Punjab

  • Study site

    Rajasthan

  • Investigational Site 4470

    Secunderbad

  • Study site

    Tamil Nadu

  • Study site

    Uttar Pradesh

  • Study site

    Vadodara

  • Study site

    Visakhapatnam

Other trials in India

France32 sites

  • Investigational Site 3314

    Agen

  • Investigational Site 3302

    Amiens

  • Investigational Site 3311

    Angers

  • Investigational Site 3321

    Annecy

  • Investigational Site 3300

    Arras

  • Investigational Site 3301

    Besançon

  • Investigational Site 3329

    Bordeaux

  • Investigational Site 3310

    Brest

  • Investigational Site 3333

    Cannes

  • Investigational Site 3327

    Colombes

  • Investigational Site 3323

    Dijon

  • Investigational Site 3307

    Grenoble

  • Investigational Site 3322

    Grenoble

  • Investigational Site 3325

    Hetztessy

  • Investigational Site 3328

    Le Mans

  • Investigational Site 3339

    Lille

  • Study site

    Lormont

  • Investigational Site 3318

    Lyon

  • Investigational Site 3303

    Montpellier

  • Study site

    Nantes

  • Investigational Site 3319

    Nice

  • Investigational Site 3308

    Paris

  • Investigational Site 3312

    Paris

  • Investigational Site 3313

    Paris

  • Investigational Site 3337

    Paris

  • Investigational Site 3335

    Pessac

  • Investigational Site 3341

    Pessac

  • Investigational Site 3336

    Pierre-Bénite

  • Study site

    Roskilde

  • Study site

    Saint Aubin Surscie

  • Investigational Site 3305

    Saint-Etienne

  • Investigational Site 3316

    Toulon

Other trials in France

Japan32 sites

  • Investigational Site 6137

    Aichi

  • Investigational Site 6104

    Aomori

  • Investigational Site 6117

    Chiba

  • Investigational Site 6119

    Fukuoka

  • Study site

    Fukuoka

  • Investigational Site 6110

    Fukushima

  • Investigational Site 6150

    Hiroshima

  • Investigational Site 6138

    Hokkaido

  • Investigational Site 6141

    Hokkaido

  • Investigational Site 6133

    Hyōgo

  • Study site

    Hyōgo

  • Investigational Site 6114

    Ishikawa

  • Investigational Site 6144

    Kagoshima

  • Investigational Site 6112

    Kanagawa

  • Investigational Site 6123

    Kumamoto

  • Investigational Site 6147

    Kumamoto

  • Investigational Site 6148

    Kumamoto

  • Investigational Site 6129

    Mie

  • Investigational Site 6146

    Nagano

  • Investigational Site 6139

    Nagasaki

  • Investigational Site 6107

    Niigata

  • Investigational Site 6152

    Okayama

  • Investigational Site 6135

    Okinawa

  • Investigational Site 6132

    Osaka

  • Investigational Site 6130

    Sapporo

  • Investigational Site 6143

    Shizuoka

  • Investigational Site 6102

    Tokyo

  • Investigational Site 6105

    Tokyo

  • Investigational Site 6113

    Tokyo

  • Investigational Site 6142

    Tokyo

  • Investigational Site 6145

    Tokyo

  • Investigational Site 6149

    Tottori

Other trials in Japan

China24 sites

  • Investigational Site 4301

    Beijing

  • Investigational Site 4302

    Beijing

  • Investigational Site 4306

    Beijing

  • Investigational Site 4321

    Beijing

  • Investigational Site 4327

    Beijing

  • Investigational Site 4337

    Beijing

  • Investigational Site 4316

    Guangzhou

  • Investigational Site 4310

    Hangzhou

  • Study site

    Hebei Province

  • Investigational Site 4325

    Jiangsu

  • Investigational Site 4317

    Kunming

  • Investigational Site 4328

    Nanjing

  • Investigational Site 4319

    Nanning

  • Investigational Site 4313

    Qingdao

  • Investigational Site 4303

    Shanghai

  • Investigational Site 4324

    Shanghai

  • Investigational Site 4330

    Shanghai

  • Investigational Site 4335

    Shanghai

  • Investigational Site 4326

    Shenyang

  • Investigational Site 4308

    Sichuan Province

  • Investigational Site 4318

    Taiyuan

  • Investigational Site 4320

    Tianjin

  • Investigational site 4338

    Xi'an

  • Investigational Site 4315

    Yinchuan

Other trials in China

Russia19 sites

  • Study site

    Barnaul

  • Investigational Site 3023

    Chelyabinsk

  • Investigational Site 3017

    Irkutsk

  • Investigational Site 3019

    Kemerovo

  • Investigational Site 3020

    Krasnoyarsk

  • Investigational Site 3030

    Krasnoyarsk

  • Investigational Site 3029

    Moscow

  • Investigational Site 3028

    Novosibirsk

  • Investigational Site 3009

    Omsk

  • Investigational Site 3022

    Ryazan

  • Investigational Site 3000

    Saint Petersburg

  • Investigational Site 3003

    Saint Petersburg

  • Investigational Site 3027

    Saint Petersburg

  • Study site

    Saratov

  • Investigational Site 3024

    Sochi

  • Investigational Site 3025

    Tyumen

  • Investigational Site 3016

    Ufa

  • Investigational Site 3004

    Yaroslavl

  • Investigational Site 3010

    Yaroslavl

Other trials in Russia

Hungary16 sites

  • Investigational Site 5413

    Baja

  • Investigational Site 5401

    Budapest

  • Investigational Site 5404

    Budapest

  • Investigational Site 5409

    Budapest

  • Investigational Site 5414

    Budapest

  • Investigational Site 5400

    Debrecen

  • Investigational Site 5402

    Kecskemét

  • Investigational Site 5405

    Kistarcsa

  • Study site

    Maglodi

  • Investigational Site 5407

    Miskolc

  • Investigational Site 5410

    Pécs

  • Study site

    Rakoczi

  • Investigational Site 5403

    Szentes

  • Investigational Site 5408

    Szombathely

  • Investigational Site 5412

    Zalaegerszeg

  • Study site

    Zrinyi

Other trials in Hungary

Germany15 sites

  • Investigational Site 1718

    Berlin

  • Investigational Site 1720

    Bielefeld

  • Investigational Site 1715

    Bruchsal

  • Investigational Site 1700

    Darmstadt

  • Investigational Site 1719

    Dortmund

  • Investigational Site 1701

    Dresden

  • Investigational Site 1707

    Dresden

  • Investigational Site 1721

    Hamburg

  • Study site

    Magdeburg

  • Investigational Site 1712

    Mainz

  • Investigational Site 1704

    München

  • Investigational Site 1714

    Nordhausen

  • Investigational Site 1711

    Paderborn

  • Investigational Site 1706

    Tübingen

  • Investigational Site 1708

    Witten

Other trials in Germany

Brazil13 sites

  • Investigational Site 2905

    Belo Horizonte

  • Investigational Site 2914

    Campinas

  • Investigational Site 2901

    Curitiba

  • Investigational Site 2903

    Curitiba

  • Investigational Site 2912

    Porto Alegre

  • Investigational Site 2915

    Porto Alegre

  • Investigational Site 2917

    Porto Alegre

  • Investigational Site 2904

    São Bernardo do Campo

  • Investigational Site 2900

    São Paulo

  • Investigational Site 2902

    São Paulo

  • Investigational Site 2906

    São Paulo

  • Investigational Site 2910

    São Paulo

  • Investigational Site 2911

    São Paulo

Other trials in Brazil

Israel13 sites

  • Study site

    Afula

  • Study site

    Ashkelon

  • Study site

    Hadera

  • Investigational Site 5506

    Haifa

  • Investigational Site 5508

    Haifa

  • Investigational Site 5500

    Holon

  • Investigational Site 5501

    Jerusalem

  • Investigational Site 5505

    Kfar Saba

  • Investigational Site 5513

    Nahariya

  • Investigational Site 5510

    Petah Tikva

  • Investigational Site 5512

    Poria – Neve Oved

  • Investigational Site 5503

    Tel Aviv

  • Investigational Site 5509

    Tel HaShomer

Other trials in Israel

Australia12 sites

  • Investigational Site 4205

    Bedford Park

  • Investigational Site 4209

    Box Hill

  • Investigational Site 4210

    Clayton

  • Investigational Site 4211

    Fremantle

  • Investigational Site 4213

    Garran

  • Study site

    Kogarah

  • Investigational Site 4207

    Perth

  • Investigational Site 4203

    Redcliffe

  • Investigational Site 4206

    Saint Leonards NSW

  • Investigational Site 4214

    South Brisbane

  • Investigational Site 4212

    Westmead NSW

  • Investigational Site 4200

    Windsor

Other trials in Australia

Italy12 sites

  • Investigational Site 3508

    Bergamo

  • Investigational Site 3506

    Chieti

  • Investigational Site 3500

    Emilia

  • Investigational Site 3504

    Milan

  • Study site

    Padova

  • Investigational Site 3502

    Palermo

  • Investigational Site 3507

    Parma

  • Investigational Site 3501

    Pavia

  • Investigational Site 3505

    Rozzano

  • Investigational Site 3510

    Udine

  • Investigational Site 3503

    Varese

  • Investigational Site 3509

    Venezia

Other trials in Italy

South Africa11 sites

  • Investigational Site 4912

    Cape Town

  • Investigational Site 4907

    Centurion

  • Investigational Site 4901

    Johannesburg

  • Investigational Site 4905

    Johannesburg

  • Investigational Site 4909

    Johannesburg

  • Investigational Site 4910

    Johannesburg

  • Investigational Site 4908

    Lyttleton

  • Investigational Site 4903

    Pretoria

  • Investigational Site 4906

    Pretoria

  • Investigational Site 4904

    Somerset West

  • Investigational Site 4900

    Worcester

Other trials in South Africa

Netherlands10 sites

  • Investigational Site 3608

    Alkmaar

  • Investigational Site 3607

    Almere Stad

  • Investigational Site 3617

    Amersfoort

  • Investigational Site 3611

    Amsterdam

  • Investigational Site 3609

    Assen

  • Investigational Site 3603

    Groningen

  • Investigational Site 3612

    Heerlen

  • Investigational Site 3613

    Hoofddorp

  • Investigational Site 3602

    Nijmegen

  • Investigational Site 3615

    Rotterdam

Other trials in Netherlands

Ukraine10 sites

  • Study site

    Chernihiv

  • Investigational Site 4008

    Dnipropetrovsk

  • Investigational Site 4010

    Donetsk

  • Investigational Site 4000

    Ivano-Frankivsk

  • Investigational Site 4002

    Kharkiv

  • Investigational Site 4001

    Kiev

  • Investigational Site 4007

    Ternopil

  • Investigational Site 4009

    Uzhhorod

  • Investigational Site 4003

    Vinnitsya

  • Investigational Site 4006

    Zaporizhzhya

Other trials in Ukraine

Czechia9 sites

  • Study site

    Chodov

  • Study site

    Jihlava

  • Investigational Site 1902

    Liberec

  • Investigational Site 1908

    Olomouc

  • Investigational Site 1905

    Ostrava

  • Investigational Site 1901

    Pilsen

  • Investigational Site 1910

    Pilsen

  • Investigational Site 1904

    Prague

  • Study site

    Ústí nad Labem

Other trials in Czechia

Mexico9 sites

  • Investigational Site 1311

    Col. Lomas Altas C.P

  • Investigational Site 1304

    Guadalajara

  • Investigational Site 1312

    Guadalajara

  • Investigational Site 1300

    Hermosillo

  • Investigational Site 1302

    Monterrey, Nuevo León

  • Investigational Site 1305

    Monterrey, Nuevo Leon

  • Investigational Site 1308

    San Luis Potosí City

  • Investigational Site 1301

    Yucatán

  • Investigational Site 1303

    Zapopan, Jalisco

Other trials in Mexico

Poland8 sites

  • Investigational Site 5015

    Bialystok

  • Investigational Site 5005

    Krakow

  • Investigational Site 5019

    Olsztyn

  • Investigational Site 5018

    Tarnów

  • Investigational Site 5003

    Warsaw

  • Investigational Site 5007

    Warsaw

  • Investigational Site 5008

    Warsaw

  • Investigational Site 5014

    Warsaw

Other trials in Poland

Argentina7 sites

  • Investigational Site 1100

    Buenos Aires

  • Investigational Site 1103

    Buenos Aires

  • Investigational Site 1106

    Buenos Aires

  • Investigational Site 1108

    Buenos Aires

  • Investigational Site 1104

    Córdoba

  • Investigational Site 1110

    Pcia de Corrientes

  • Investigational Site 1109

    Santa Fe

Other trials in Argentina

Canada7 sites

  • Investigational Site 2006

    Edmonton, Alberta

  • Investigational Site 2005

    Halifax

  • Investigational Site 2001

    London, Ontario

  • Investigational Site 2004

    Montreal

  • Investigational Site 2007

    Newmarket, Ontario

  • Investigational Site 2000

    Ottawa, Ontario

  • Investigational Site 2003

    Richmond Hill, Ontario

Other trials in Canada

South Korea7 sites

  • Investigational Site 4513

    Busan

  • Investigational Site 4509

    Daegu

  • Investigational Site 4501

    Gyeonggi-do

  • Investigational Site 4506

    Seoul

  • Investigational Site 4507

    Seoul

  • Investigational Site 4508

    Seoul

  • Investigational Site 4515

    Seoul

Other trials in South Korea

United Kingdom7 sites

  • Investigational Site 7005

    Coventry

  • Investigational Site 7006

    Hull

  • Investigational Site 7000

    London

  • Investigational Site 7003

    London

  • Investigational Site 7004

    London

  • Investigational Site 7001

    Newcastle

  • Investigational Site 7007

    Plymouth

Other trials in United Kingdom

Austria6 sites

  • Investigational Site 2802

    Feldkirch

  • Investigational Site 2803

    Graz

  • Investigational Site 2800

    Innsbruck

  • Investigational Site 2804

    Linz

  • Study site

    Sr. M. Restitutagasse

  • Study site

    Vienna

Other trials in Austria

Belarus6 sites

  • Investigational Site 2704

    Grodno

  • Investigational Site 2703

    Homyel

  • Investigational Site 2700

    Minsk

  • Investigational site 2701

    Minsk

  • Investigational Site 2702

    Minsk

  • Investigational Site 2705

    Mogilev

Other trials in Belarus

Denmark6 sites

  • Investigational Site 6010

    Aarhus

  • Study site

    Arhus N.

  • Study site

    Copenhagen

  • Investigational Site 6003

    Herlev

  • Study site

    Ringvej

  • Investigational Site 6001

    Svendborg

Other trials in Denmark

Switzerland6 sites

  • Investigational Site 4103

    Aarau

  • Investigational Site 4110

    Basel

  • Investigational Site 4104

    Bellinzona

  • Investigational Site 4102

    Chur

  • Investigational Site 4109

    Lausanne

  • Investigational Site 4100

    Lucerne

Other trials in Switzerland

Sweden5 sites

  • Investigational Site 3900

    Hällingsjö

  • Investigational Site 3904

    Kristianstad

  • Investigational Site 3903

    Stockholm

  • Investigational Site 3905

    Stockholm

  • Investigational Site 3902

    Sundsvall

Other trials in Sweden

Taiwan5 sites

  • Study site

    Hualien City

  • Investigational Site 5104

    Kaohsiung City

  • Investigational Site 5105

    Taichung

  • Investigational Site 5101

    Taipei

  • Investigational Site 5103

    Taipei

Other trials in Taiwan

New Zealand4 sites

  • Investigational Site 4702

    Auckland

  • Investigational Site 4703

    Auckland

  • Investigational Site 4700

    Christchurch

  • Investigational Site 4704

    Wellington

Other trials in New Zealand

Philippines4 sites

  • Study site

    Pasig

  • Investigational Site 4800

    Quezon City

  • Investigational site 4801

    Quezon City

  • Investigational Site 4802

    Quezon City

Other trials in Philippines

Turkey (Türkiye)4 sites

  • Investigational Site 5702

    Ankara

  • Investigational Site 5703

    Ankara

  • Investigational Site 5702

    Istanbul

  • Investigational Site 5706

    Istanbul

Other trials in Turkey (Türkiye)

Estonia3 sites

  • Investigational Site 2100

    Tallinn

  • Investigational Site 2101

    Tallinn

  • Investigational Site 2102

    Tartu

Other trials in Estonia

Thailand3 sites

  • Investigational Site 5200

    Bangkok

  • Investigational Site 5202

    Bangkok

  • Investigational Site 5203

    Nakhorn Nayok

Other trials in Thailand

Belgium2 sites

  • Investigational Site 1608

    Aalst

  • Investigational Site 1602

    Lier

Other trials in Belgium

Chile2 sites

  • Investigational Site 1200

    Santiago

  • Investigational Site 1204

    Santiago

Other trials in Chile

Norway2 sites

  • Investigational Site 3701

    Fredrikstad

  • Investigational Site 3700

    Oslo

Other trials in Norway

Singapore2 sites

  • Investigational Site 5900

    Outram Road

  • Investigational Site 5902

    Singapore

Other trials in Singapore

Spain2 sites

  • Investigational site 1503

    Barcelona

  • Investigational Site 1502

    Cabra

Other trials in Spain

About this study

Official title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

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.

Being tested
edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin, warfarin
Keywords
Recurrent Thrombosis, Recurrent Pulmonary Embolism, Symptomatic Deep Vein Thrombosis, Symptomatic Pulmonary Embolism, Venous Thromboembolism (VTE)
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thromboembolism, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • edoxaban tosylate(DU-176b)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 heparinDrug

    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

  • warfarinDrug

    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

Study groups in NCT00986154
Study groupRoleWhat they receive
heparin/edoxaban tosylateExperimentalNot described
Receives: Drug: edoxaban tosylate(DU-176b); Drug: low molecular weight heparin/unfractionated heparin
heparin/warfarinActive comparatorNot described
Receives: Drug: low molecular weight heparin/unfractionated heparin; Drug: warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE

    Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.

    Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."

    Measured: 12 months from time of randomization

Secondary outcomes (2)

  1. The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality

    Measured: 12 months from time of randomization

  2. Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment

    Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.

    Measured: 12 months from time of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
8,292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00986154
Sponsor's protocol ID
DU176b-D-U305
Other IDs
The Edoxaban Hokusai VTE Study
Status last verified
Mar 2015
First submitted
25 Sep 2009
Last updated
5 Mar 2019
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Christodoulou KC, Barco S, Abele C, Lodigiani C, Monreal M, Konstantinides SV, Valerio L. Burden of Atherosclerosis and Outcomes of Acute Pulmonary Embolism: A Post Hoc Analysis of the Hokusai-VTE Trial. J Am Heart Assoc. 2025 Nov 18;14(22):e041420. doi: 10.1161/JAHA.125.041420. Epub 2025 Nov 6.

    PubMed 41195787

  • Barco S, Abele C, Ageno W, Klok FA, Wenzel P, Trinchero A, Malcovati L, Konstantinides SV, Valerio L. Warfarin reduces circulating white blood cell count: Post-hoc analysis of two randomized trials. Thromb Res. 2025 Oct;254:109452. doi: 10.1016/j.thromres.2025.109452. Epub 2025 Sep 5.

    PubMed 40925065

  • 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.

    PubMed 29248859

  • 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.

    PubMed 28689179

  • 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.

    PubMed 27570090

  • 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.

    PubMed 27476789

  • 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.

    PubMed 26179767

  • 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.

    PubMed 23991658

  • 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.

    PubMed 21861537

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin and warfarin in people with Venous Thromboembolism and Deep Vein Thrombosis (DVT), run by Daiichi Sankyo at 454 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 454 sites in United States, India, France, Japan, China and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (time frame: 12 months from time of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00986154, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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