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

PHASE3CompletedINTERVENTIONAL
Enrollment

5,614

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Venous Thrombosis
Interventions
DRUG

Enoxaparin

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

DRUG

warfarin

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

DRUG

Placebo for apixaban

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

DRUG

Placebo for enoxaparin

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

DRUG

Placebo for warfarin

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

DRUG

apixaban

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

Trial Locations (381)

1032

Local Institution, Budapest

1090

Local Institution, Vienna

1097

Local Institution, Budapest

1100

Local Institution, Vienna

1125

Local Institution, Budapest

1140

Local Institution, Vienna

1160

Local Institution, Vienna

1346

Local Institution, Gjettum

1606

Local Institution, Fredrikstad

2000

Local Institution, Rosario

2031

Local Institution, Randwick

2139

Local Institution, Concord

2193

Local Institution, Parktown

2217

Local Institution, Kogarah

2318

Local Institution, Hamar

2480

Local Institution, Lismore

2500

Local Institution, Tynset

2605

Local Institution, Garran

2819

Local Institution, Gjøvik

2900

Local Institution, Hellerup

3128

Local Institution, Box Hill

3135

Local Institution, Ringwood East

3168

Local Institution, Clayton

3181

Local Institution, Windsor

3201

Local Institution, Pietermaritzburg

3400

Local Institution, Corrientes

Local Institution, Hilleroed

3501

Local Institution, Miskolc

4001

Local Institution, Durban

4029

Local Institution, Herston

4700

Local Institution, Næstved

5000

Local Institution, Córdoba

Local Institution, Adelaide

5042

Local Institution, Bedford Park

5700

Local Institution, Gyula

6000

Local Institution, Kecskemét

6001

Local Institution, Perth

6017

Local Institution, Ålesund

6020

Local Institution, Innsbruck

6529

Local Institution, George

6850

Local Institution, Worcester

7000

Local Institution, Hobart

7006

Local Institution, Trondheim

7130

Local Institution, Somerset West

7400

Local Institution, Herning

7530

Local Institution, Bellville

8000

Local Institution, Arhus C

Local Institution, Székesfehérvár

8036

Local Institution, Graz

8600

Local Institution, Silkeborg

8700

Local Institution, Horsens

8900

Local Institution, Zalaegerszeg

9200

Local Institution, Mosonmagyaróvár

9301

Local Institution, Bioemfontein

10117

Local Institution, Berlin

10310

Richmond University Medical Center, Staten Island

10350

Local Institution, George Town

10595

New York Medical College, Valhalla

10787

Local Institution, Berlin

12205

Pulmonary & Critical Care Services, Pc, Albany

12559

Local Institution, Berlin

13100

Local Institution, Safed

14034

Local Institution, Chernihiv

14050

Local Institution, Berlin

14209

Kaleida Health System, Buffalo

15090

Local Institution, São José do Rio Preto

15208

Local Institution, Tiberias

17033

Penn State Milton S. Hershey Medical Center, Hershey

18101

Local Institution, Afula

18618

Local Institution, Botucatu

20037

George Washington University Medical Faculty Associates, Washington D.C.

20089

Local Institution, Rozzano (Mi)

20132

Local Institution, Milan

20230

Local Institution, Aguascalientes

20551

Local Institution, Rio de Janeiro

21018

Local Institution, Vinnytsia

21079

Local Institution, Dijon

21201

R Adams Cowley Shock Trauma Center, Baltimore

21237

Medstar Research Health Institute, Baltimore

21401

Anne Arundel Medical Center, Annapolis

22100

Local Institution, Nahariya

22280

Local Institution, Rio Janeiro

22500

Local Institution, Tijuana

24008

Local Institution, León

25000

Local Institution, Besançon

27100

Local Institution, Pavia

27103

Clinical Trials Of America, Inc., Winston-Salem

27200

Local Institution, Vernon

27607

Rex Healthcare, Raleigh

27710

Duke University Medical Center, Durham

28007

Local Institution, Madrid

28029

Local Institution, Madrid

28041

Local Institution, Madrid

28203

Carolinas Medical Center, Charlotte

28401

Wilmington Medical Research, Wilmington

28625

Piedmont Healthcare/Research, Statesville

28905

Local Institution, Getafe

29010

Local Institution, Málaga

29100

Local Institution, Piacenza

29485

Palmetto Clinical Research, Summerville

29615

Greenville Hospital System, Greenville

30030

Atlanta Institute For Medical Research, Inc, Decatur

30150

Local Institution, Belo Horizonte - Mg

30342

Atlanta Pulmonary Group, Atlanta

30990

Local Institution, Ipoh

31029

Local Institution, Vittorio Veneto (Tv)

31033

Local Institution, Castelfranco Veneto (Tv)

31048

Local Institution, Haifa

31059

Local Institution, Toulouse

31096

Local Institution, Haifa

31405

Chatham Hospitalists, Savannah

32207

River City Clinical Research, Jacksonville

32960

Office Of Michele S. Maholtz Md, Vero Beach

33038

Local Institution, San Daniele Del Friuli (Ud)

33331

Cleveland Clinic Florida, Weston

33511

Daniel G. Lorch, Jr, Md, Cpi, Brandon

33624

Tampa Clinical Research, Tampa

33707

Pasadena Center For Medical Research, St. Petersburg

33744

Bay Pines Va Healthcare Systems, Bay Pines

33756

Research Alliance, Inc., Clearwater

34080

Local Institution, Durango

35128

Local Institution, Padua

35235

Alabama Clinical Therapeutics, Llc, Birmingham

36071

Local Institution, Mourente

36100

Local Institution, Vicenza

36608

Horizon Research Group, Inc., Mobile

37075

Local Institution, Göttingen

37320

Local Institution, León

37620

Holston Medical Group, Bristol

38043

Local Institution, Grenoble

38101

Local Institution, Hadera

38305

Kore Cv Research, Jackson

39466

Mississippi Medical Research, Llc, Picayune

40138

Local Institution, Bologna

40536

Univ. Of Kentucky Dept. Of Surgery, Lexington

41701

Kentucky Lung Clinic, Hazard

42100

Local Institution, Reggio Emilia

42270

Local Institution, Saint-Priest-en-Jarez

42303

Research Integrity, Llc, Owensboro

43007

Local Institution, Tarragona

43215

Remington Davis Inc., Columbus

44093

Local Institution, Nantes

44112

Huron Hospital, Cleveland

44137

Local Institution, Dortmund

44280

Local Institution, Guadalajara

44281

Local Institution, Kfar Saba

44791

Local Institution, Bochum

45170

Local Institution, Zapopan

45200

Local Institution, Zapopan

46000

Local Institution, Ternopil

46032

Infectious Disease Of Indiana Psc, Carmel

48202

Henry Ford Hospital, Detroit

48503

Hurley Medical Center, Flint

49000

Local Institution, Angers

Local Institution, Dnipropetrovsk

49100

Local Institution, Petah Tikva

50324

Heartland Vascular Medicine And Surgery, Windsor Heights

50586

Local Institution, Kuala Lumpur

50937

Local Institution, Cologne

52206

Local Institution, Langres

52621

Local Institution, Tel Litwinsky

56124

Local Institution, Pisa

58100

Local Institution, Holon

58201

Altru Health System Clinic, Grand Forks

59020

Local Institution, Lille

59405

Great Falls Clinic, Llp, Great Falls

59701

Mercury Street Medical Group, Pllc, Butte

60302

West Suburban Medical Center, Oak Park

60596

Local Institution, Frankfurt

61018

Local Institution, Kharkiv

62022

Local Institution, Arras

62052

Gateway Cardiology. P.C, Jerseyville

63003

Local Institution, Clermont-Ferrand

63110

Washington University School Of Medicine, St Louis

63141

St. John'S Mercy Medical Center, St Louis

64000

Local Institution, Monterrey

64128

Veterans Affairs Medical Center, Kansas City

64239

Local Institution, Tel Aviv

64718

Local Institution, Monterrey

65117

Local Institution, Odesa

65212

University Of Missouri-Columbia, Columbia

66013

Local Institution, Chieti Scalo

67063

Local Institution, Ludwigshafen

68131

Creighton University Medical Center, Omaha

68161

Local Institution, Mannheim

68163

Local Institution, Mannheim

68803

Internal Medical Associates Of Grand Island, P.C, Grand Island

69035

Local Institution, Zaporizhzhia

69495

Local Institution, Pierre-Bénite

72205

University Of Arkansas For Medical Sciences, Little Rock

72901

Fort Smith Lung Center, Fort Smith

75004

Local Institution, Paris

75010

Local Institution, Paris

75400

Local Institution, Malacca

76008

Local Institution, Ivano-Frankivsk

76018

Local Institution, Ivano-Frankivsk

76100

Local Institution, Rehovot

76307

Local Institution, Karlsbad

77024

Primecare Medical Group, Houston

78229

Cancer Care Centers Of South Texas, San Antonio

78278

Local Institution, Ashkelon

79010

Local Institution, Lviv

80033

Drogue Medical, Llc, Wheat Ridge

80035

Local Institution, Curitiba

80050

Local Institution, Curitiba

80331

Local Institution, München

80336

Local Institution, Munich

80401

New West Physicians, Golden

80810

Local Institution, Curitiba

81520

Local Institution, Curitiba

83045

Local Institution, Donetsk

84132

University Of Utah Medical Center, Salt Lake City

87042

Local Institution, Limoges

87100

Local Institution, Cosenza

90020

Local Institution, Port Alegre

90035

Local Institution, Porto Alegre

90110

Local Institution, Porto Alegre

90127

Local Institution, Palermo

90509

Harbor Ucla Medical Center, Torrance

90610

Local Institution, Porto Alegre

91020

Local Institution, Xalapa

91031

Local Institution, Jerusalem

91120

Local Institution, Jerusalem

92123

Chest Medicine & Critical Care Medical Gr. Inc., San Diego

92141

Local Institution, Clamart

92220

Beaver Medical Group, Banning

93701

University Of California San Francisco-Fresno, Fresno

94275

Local Institution, Le Kremlin-Bicêtre

94305

Stanford University Medical Center, Stanford

95817

University Of California, Davis Medical Center, Sacramento

97239

Oregon Health Science University, Portland

98004

Lake Washington Vascular, Pllc, Bellevue

98405

Franciscan Research Center, Tacoma

100020

Local Institution, Beijing

100029

Local Institution, Beijing

100032

Local Institution, Beijing

100035

Local Institution, Beijing

100037

Local Institution, Beijing

100038

Local Institution, Beijing

100053

Local Institution, Beijing

100191

Local Institution, Beijing

109386

Local Institution, Moscow

110004

Local Institution, Shengyang

111539

Local Institution, Moscow

115093

Local Institution, Moscow

115280

Local Institution, Moscow

117292

Local Institution, Moscow

119049

Local Institution, Moscow

120752

Local Institution, Seoul

121359

Local Institution, Moscow

121552

Local Institution, Moscow

122001

Local Institution, Gurgaon

127473

Local Institution, Moscow

130016

Local Institution, Hangzhou

138736

Local Institution, Seoul

141001

Local Institution, Ludhiana

150062

Local Institution, Yaroslavl

160062

Local Institution, Mohali

163045

Local Institution, Arkhangelsk

169608

Local Institution, Singapore

192242

Local Institution, Saint Petersburg

194044

Local Institution, Saint Petersburg

196247

Local Institution, Saint Petersburg

197022

Local Institution, Saint Petersburg

197341

Local Institution, Saint Petersburg

199106

Local Institution, Saint Petersburg

200032

Local Institution, Shanghai

200127

Local Institution, Shanghai

308433

Local Institution, Singapore

310016

Local Institution, Hangzhou

344022

Local Institution, Rostov-on-Don

380006

Local Institution, Ahmedabad

390026

Local Institution, Ryazan

410012

Local Institution, Saratov

411001

Local Institution, Pune

Local Institution, Pune

420101

Local Institution, Kazan'

430022

Local Institution, Wuhan

430031

Local Institution, Baia Mare

454136

Local Institution, Chelyabinsk

500034

Local Institution, Hyderabad

510080

Local Institution, Guangzhou

529889

Local Institution, Singapore

540136

Local Institution, Târgu Mureş

560017

Local Institution, Bengaluru

560052

Local Institution, Bangalore

560054

Local Institution, Bangalore

560099

Local Institution, Bangalore

576104

Local Institution, Manipal

630090

Local Institution, Novosibirsk

710032

Local Institution, Xi'an

2520000

Local Institution, Viña del Mar

6212296

Local Institution, Punta Arenas

7600448

Local Institution, Santiago

8330024

Local Institution, Santiago

06610

Bridgeport Hospital, Bridgeport

06510

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

04856

Pen Bay Medical Center, Rockport

07962

Morristown Memorial Hospital, Morristown

C1280AEB

Local Institution, Buenos Aires

C1180AAX

Local Institution, Ciudad Autonoma de Buenos Aire

S2000CVB

Local Institution, Rosario

S2000DSV

Local Institution, Rosario

01509

Local Institution, Liberdade

09715

Local Institution, São Bernardo do Campo

01323

Local Institution, São Paulo

04005

Local Institution, São Paulo

04025

Local Institution, São Paulo

05403

Local Institution, São Paulo

T5H 4B9

Local Institution, Edmonton

T6G 2B7

Local Institution, Edmonton

V5Z 1M9

Local Institution, Vancouver

V6Z 1Y6

Local Institution, Vancouver

V8R 6R5

Local Institution, Victoria

R2H 2A6

Local Institution, Winnipeg

E2L 4L2

Local Institution, Saint John

L8L 2X2

Local Institution, Hamilton

L8N 4A6

Local Institution, Hamilton

L8S 4K1

Local Institution, Hamilton

K1Y 4E9

Local Institution, Ottawa

M5G 2C4

Local Institution, Toronto

N2J 1C4

Local Institution, Waterloo

N8X 5A6

Local Institution, Windsor

J4V 2H1

Local Institution, Greenfield Park

H1T 2M4

Local Institution, Montreal

J7Z 5T3

Local Institution, Saint-Jérôme

XXXXX

Local Institution, Independencia

Local Institution, Pokfulman

500 05

Local Institution, Hradec Králové

272 59

Local Institution, Kladno

570 14

Local Institution, Litomyšl

289 03

Local Institution, Městec Králové

708 52

Local Institution, Ostrava

703 84

Local Institution, Ostrava Vitkovice

100 34

Local Institution, Prague

110 00

Local Institution, Prague

118 33

Local Institution, Prague

128 08

Local Institution, Prague

401 13

Local Institution, Ústí nad Labem

562 18

Local Institution, Ústí nad Orlicí

01067

Local Institution, Dresden

01307

Local Institution, Dresden

Unknown

Local Institution, Shatin, N.T

500 082

Local Institution, Hyderabad

600 006

Local Institution, Chennai

00168

Local Institution, Rome

0319

Local Institution, Oslo

0407

Local Institution, Oslo

0456

Local Institution, Oslo

15-276

Local Institution, Bialystok

85-168

Local Institution, Bydgoszcz

85-681

Local Institution, Bydgoszcz

80-803

Local Institution, Gdansk

81-348

Local Institution, Gdynia

90-153

Local Institution, Lodz

20-081

Local Institution, Lublin

20-718

Local Institution, Lublin

61-848

Local Institution, Poznan

37-200

Local Institution, Przeworsk

70-111

Local Institution, Szczecin

01-138

Local Institution, Warsaw

02-005

Local Institution, Warsaw

02-776

Local Institution, Warsaw

50-981

Local Institution, Wroclaw

51-124

Local Institution, Wroclaw

3004-548

Local Institution, Coimbra

6301-857

Local Institution, Guarda

1169-050

Local Institution, Lisbon

1769-001

Local Institution, Lisbon

00921

Local Institution, San Juan

022328

Local Institution, Bucharest

030171

Local Institution, Bucharest

050098

Local Institution, Bucharest

0157

Local Institution, Centurion

0084

Local Institution, Pretoria

602-702

Local Institution, Busan

137-040

Local Institution, Seoul

03186

Local Institution, Torrevieja

08907

Local Institution, L'Hospitalet de Llobregat

03680

Local Institution, Kyiv

EH54 7BH

Local Institution, Livingston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY

NCT00643201 - Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism | Biotech Hunter | Biotech Hunter