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).

PHASE3CompletedINTERVENTIONAL
Enrollment

8,292

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Venous ThromboembolismDeep Vein Thrombosis (DVT)Pulmonary Embolism (PE)ThromboembolismVenous Thrombosis
Interventions
DRUG

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

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"

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

Trial Locations (454)

14642

Investigational Site 7143, Rochester

17011

Investigational Site 1004, Camp Hill

17522

Investigational Site 7109, Ephrata

17602

Investigational Site 7109, Lancaster

18704

Investigational Site 1049, Kingston

21157

Investigational Site 1037, Westminster

Investigational Site 1038, Westminster

21215

Investigational Site 1068, Baltimore

27710

Investigational Site 7135, Durham

28625

Investigational Site 7145, Statesville

29307

Investigational Site 1036, Spartanburg

29605

Investigational Site 1032, Greenville

Investigational Site 1034, Greenville

29615

Investigational Site 1033, Greenville

29640

Investigational Site 1031, Easley

29672

Investigational Site 1035, Seneca

30236

Investigational Site 1080, Jonesboro

31419

Investigational Site 7146, Savannah

31701

Investigational Site 7104, Albany

31904

Investigational Site 1095, Columbus

32605

Investigational Site 7106, Gainesville

32789

Investigational Site 1007, Winter Park

32806

Investigational Site 1006, Orlando

33707

Investigational Site 7127, St. Petersburg

33756

Investigational Site 1071, Clearwater

33907

Investigational Site 7117, Fort Myers

34232

Investigational Site 7144, Sarasota

34761

Investigational Site 1005, Ocoee

36116

Investigational Site 7132, Montgomery

36608

Investigational Site 7103, Mobile

42003

Investigational Site 7115, Paducah

43537

Investigational Site 7138, Maumee

43606

Investigational Site 7122, Toledo

59701

Investigational Site 7147, Butte

60068

Investigational Site 1098, Park Ridge

64128

Investigational Site 7133, Kansas City

70433

Investigational Site 1065, Covington

72205

Investigational Site 7139, Little Rock

76104

Investigational Site 1047, Fort Worth

76109

Investigational Site 7105, Fort Worth

76132

Investigational Site 1048, Fort Worth

78130

Investigational Site 1040, New Braunfels

78229

Investigational Site 1002, San Antonio

80012

Investigational Site 1012, Aurora

80218

Investigational Site 1017, Denver

80228

Investigational Site 1018, Lakewood

80260

Investigational Site 1022, Thornton

Investigational Site 1023, Thornton

80303

Investigational Site 1013, Boulder

85006

Investigational Site 7126, Phoenix

89169

Investigational Site 1039, Las Vegas

90720

Investigational Site 7125, Los Alamitos

92083

Investigational Site 1089, Vista

92123

Investigational Site 7150, San Diego

92262

Investigational Site 1069, Palm Springs

92801

Investigational Site 1070, Anaheim

93940

Investigational Site 1093, Monterey

97701

Investigational Site 7152, Bend

80120-4413

Investigational Site 1019, Littleton

Unknown

Brandon

Carmel

Portland

Investigational Site 7154, Sellersville

Investigational Site 7128, Uniontown

Investigational Site 1050, Dallas

Investigational Site 1059, Midland

Investigational Site 1041, Odessa

Investigational Site 1058, Sugar Land

Investigational Site 1042, Tyler

Investigational Site 1008, Waco

Investigational Site 7123, Salt Lake City

Investigational Site 1003, Fredericksburg

Investigational Site 1025, Newport News

Investigational Site 1024, Norfolk

Investigational Site 1066, Randallstown

Investigational Site 1030, Virginia Beach

Investigational Site 7120, Seattle

Investigational Site 1076, Tacoma

Investigational Site 1053, Vancouver

Investigational Site 1056, Vancouver

Investigational Site 1057, Vancouver

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

Investigational Site 4205, Bedford Park

Investigational Site 4209, Box Hill

Investigational Site 4210, Clayton

Investigational Site 4211, Fremantle

Investigational Site 4213, Garran

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

Investigational Site 2802, Feldkirch

Investigational Site 2803, Graz

Investigational Site 2800, Innsbruck

Investigational Site 2804, Linz

Sr. M. Restitutagasse

Vienna

Investigational Site 2704, Grodno

Investigational Site 2703, Homyel

Investigational Site 2700, Minsk

Investigational site 2701, Minsk

Investigational Site 2702, Minsk

Investigational Site 2705, Mogilev

Investigational Site 1608, Aalst

Investigational Site 1602, Lier

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

Investigational Site 2006, Edmonton

Investigational Site 2001, London

Investigational Site 2007, Newmarket

Investigational Site 2000, Ottawa

Investigational Site 2003, Richmond Hill

Investigational Site 2005, Halifax

Investigational Site 2004, Montreal

Investigational Site 1200, Santiago

Investigational Site 1204, Santiago

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

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

Chodov

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

Ústí nad Labem

Investigational Site 6010, Aarhus

Arhus N.

Copenhagen

Investigational Site 6003, Herlev

Ringvej

Investigational Site 6001, Svendborg

Investigational Site 2100, Tallinn

Investigational Site 2101, Tallinn

Investigational Site 2102, Tartu

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

Lormont

Investigational Site 3318, Lyon

Investigational Site 3303, Montpellier

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

Roskilde

Saint Aubin Surscie

Investigational Site 3305, Saint-Etienne

Investigational Site 3316, Toulon

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

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

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

Maglodi

Investigational Site 5407, Miskolc

Investigational Site 5410, Pécs

Rakoczi

Investigational Site 5403, Szentes

Investigational Site 5408, Szombathely

Investigational Site 5412, Zalaegerszeg

Zrinyi

Ahmedabad

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

Gujarat

Gūrgaon

Haryāna

Investigational Site 5514, Holon

Investigational Site 4407, Hyderabad

Investigational Site 4430, Hyderabad

Investigational Site 4444, Hyderabad

Investigational Site 4451, Hyderabad

Karnataka

Kerala

Investigational Site 4420, Lucknow

Madhya Pradesh

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

Punjab

Rajasthan

Investigational Site 4470, Secunderbad

Tamil Nadu

Uttar Pradesh

Vadodara

Visakhapatnam

Afula

Ashkelon

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 Litwinsky

Investigational Site 3508, Bergamo

Investigational Site 3506, Chieti

Investigational Site 3500, Emilia

Investigational Site 3504, Milan

Padua

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

Investigational Site 6137, Aichi

Investigational Site 6104, Aomori

Investigational Site 6117, Chiba

Investigational Site 6119, Fukuoka

Fukuoka

Investigational Site 6110, Fukushima

Investigational Site 6150, Hiroshima

Investigational Site 6138, Hokkaido

Investigational Site 6141, Hokkaido

Investigational Site 6133, Hyōgo

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

Investigational Site 1303, Zapopan

Investigational Site 1302, Monterrey

Investigational Site 1311, Col. Lomas Altas C.P

Investigational Site 1304, Guadalajara

Investigational Site 1312, Guadalajara

Investigational Site 1300, Hermosillo

Investigational Site 1305, Monterrey, Nuevo Leon

Investigational Site 1308, San Luis Potosí City

Investigational Site 1301, Yucatán

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

Investigational Site 4702, Auckland

Investigational Site 4703, Auckland

Investigational Site 4700, Christchurch

Investigational Site 4704, Wellington

Investigational Site 3701, Fredrikstad

Investigational Site 3700, Oslo

Pasig

Investigational Site 4800, Quezon City

Investigational site 4801, Quezon City

Investigational Site 4802, Quezon City

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

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

Saratov

Investigational Site 3024, Sochi

Investigational Site 3025, Tyumen

Investigational Site 3016, Ufa

Investigational Site 3004, Yaroslavl

Investigational Site 3010, Yaroslavl

Investigational Site 5900, Outram Road

Investigational Site 5902, Singapore

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

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

Investigational site 1503, Barcelona

Investigational Site 1502, Cabra

Investigational Site 3900, Hällingsjö

Investigational Site 3904, Kristianstad

Investigational Site 3903, Stockholm

Investigational Site 3905, Stockholm

Investigational Site 3902, Sundsvall

Investigational Site 4103, Aarau

Investigational Site 4110, Basel

Investigational Site 4104, Bellinzona

Investigational Site 4102, Chur

Investigational Site 4109, Lausanne

Investigational Site 4100, Lucerne

Hualien City

Investigational Site 5104, Kaohsiung City

Investigational Site 5105, Taichung

Investigational Site 5101, Taipei

Investigational Site 5103, Taipei

Investigational Site 5200, Bangkok

Investigational Site 5202, Bangkok

Investigational Site 5203, Nakhorn Nayok

Investigational Site 5702, Ankara

Investigational Site 5703, Ankara

Investigational Site 5702, Istanbul

Investigational Site 5706, Istanbul

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, Zaporizhzhia

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

76014-2084

Investigational Site 1009, Arlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT00986154 - 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). | Biotech Hunter | Biotech Hunter