Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

7,513

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2016

Conditions
Venous Thromboembolism (VTE)
Interventions
DRUG

Betrixaban

"Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.~Enoxaparin Placebo: Once daily, 6-14 days"

DRUG

Enoxaparin

"Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.~Betrixaban Placebo: once daily, 35 days"

Trial Locations (462)

18

Lima

1000

Zagreb

1070

Brussels

1097

Budapest

1100

Vienna

1122

Budapest

1125

Budapest

1134

Budapest

1145

Budapest

1160

Vienna

1202

Sofia

1233

Sofia

1280

Buenos Aires

1407

Sofia

1606

Sofia

1618

El Talar

1784

Sofia

2021

Johannesburg

2143

Kistarcsa

2193

Johannesburg

2660

Balassagyarmat

2700

Cegléd

2800

Sandanski

3000

Leuven

3300

Eger

4002

Plovdiv

4020

Redcliffe

Linz

4032

Debrecen

4100

Berettyóújfalu

4500

Huy

5000

Córdoba

Szolnok

5042

Bedford Park

5300

Gabrovo

5530

Yvoir

5700

Gyula

5800

Pleven

6009

Nedlands

6500

Baja

6511

Zams

6800

Feldkirch

Hódmezövásárhely

6850

Worcester

7100

Szekszárd

7530

Cape Town

7700

Mohács

8036

Graz

8112

Gratwein

8200

Veszprém

8230

Hartberg

8231

Balatonfüred

8600

Yambol

8800

Sliven

Nagykanizsa

8900

Leper

Zalaegerszeg

10000

Zagreb

10305

Staten Island

10595

Valhalla

10787

Berlin

11000

Belgrade

11030

Manhasset

13100

Safed

14209

Buffalo

16128

Genova

17007

Girona

17011

Camp Hill

17800

Olot

18000

Niš

18101

Afula

18205

Niška Banja

19107

Philadelphia

20021

Bollate

20085

Milan

20132

Milan

21005

Vinnytsia

21079

Dijon

21100

Varese

21204

Kamenitz

21287

Baltimore

21401

Annapolis

22559

Hamburg

22908

Charlottesville

23000

Zadar

23249

Richmond

25006

Kirovograd

25701

Huntington

26000

Pančevo

27100

Pavia

27207

Vernon

27710

Durham

28007

Madrid

28034

Madrid

28151

Utena

28222

Majadahonda

28702

San Sebastián de los Reyes

29107

Quimper

29118

Orangeburg

29121

Piacenza

29200

Brest

29425

Charleston

29609

Brest

30030

Decatur

30122

Venezia

30202

Cartagena

31029

Vittorio Veneto TV

31033

Castelfranco Veneto

31048

Haifa

31096

Haifa

31904

Columbus

32216

Jacksonville

32429

Minden

32504

Pensacola

32960

Vero Beach

33001

Rivne

33075

Bordeaux

33098

Paderborn

33143

Miami

33744

Bay Pines

33756

Clearwater

34000

Kragujevac

34170

Castelnau-le-Lez

34232

Sarasota

34295

Montpellier

35203

Rennes

35294

Birmingham

36001

Pontevedra

36204

Vigo

37007

Salamanca

38043

La Tronche

39120

Magdeburg

39466

Picayune

Picayune

40001

Cluj-Napoca

41063

Möchengladbach

41464

Neuss

41701

Hazard

42000

Varaždin

42055

Saint-Priest En Jarrez

42100

Reggio Emilia

43007

Tarragona

43024

Lutsk

43100

Parma

43210

Columbus

44093

Nantes

44281

Kfar Saba

45147

Essen

45267

Cincinnati

46032

Carmel

46045

Oberhausen

46483

Wesel

48073

Royal Oak

48085

Troy

48202

Detroit

48439

Grand Blanc

49100

Angers

Petah Tikva

49217

Krapinske Toplice

50134

Frenze

50324

Windsor Heights

51000

Rijeka

52100

Pula

52803

Davenport

53115

Bonn

55131

Mainz

55805

Duluth

58455

Witten

59020

Lille

59200

Tourcoing

59300

Valenciennes

59400

Cambrai

59701

Butte

60302

Oak Park

60611

Chicago

61018

Kharkiv

61039

Kharkiv

61058

Kharkiv

61176

Kharkiv

62022

Arras

63003

Clermont-Ferrand

63110

St Louis

64111

Kansas City

64239

Tel Aviv

65009

Odesa

65014

Odesa

65025

Odesa

65199

Wiesbaden

65428

Rüsselsheim am Main

66604

Topeka

67063

Ludwigshafen

68131

Omaha

69000

Zaporizhzhya

69065

Zaporizhzhya

69120

Heidelberg

69495

Pierre-Bénite

70300

Ẕerifin

70710

Brasília

72037

Le Mans

73039

Kherson

74173

Bad Friedrichshall

75004

Paris

75010

Paris

75110

Corsicana

75216

Dallas

75908

Paris

76008

Ivano-Frankivsk

76104

Fort Worth

76230

Bois-Guillaume

76307

Karlbad

76701

Kroměříž

77024

Houston

77030

Houston

77401

Bellaire

77901

Victoria

78205

San Antonio

78258

San Antonio

78278

Ashkelon

78501

McAllen

78572

Mission

78705

Austin

78752

Austin

79010

Lviv

80113

Englewood

80131

Napoli

83045

Donetsk

83114

Donetsk

83305

Bratislava

84918

Avignon

88000

Uzhhorod

89109

Las Vegas

89502

Reno

90073

Los Angeles

90509

Torrance

90822

Long Beach

91011

Luhansk

91120

Jerusalem

91942

La Mesa

92120

San Diego

92637

Weiden

92700

Colombes

93308

Bakersfield

93701

Fresno

94305

Stanford

94901

Nitra

95026

Simferopol

95350

Modesto

97400

Yevpatoria

98201

Everett

110884

Piteşti

111539

Moscow

117292

Moscow

119074

Singapore

119881

Moscow

119992

Moscow

121552

Moscow

127473

Moscow

140006

Lubertsy

150003

Yaroslavl

150030

Yaroslavl

163045

Arkhangelsk

169608

Singapore

169609

Singapore

170000

La Serena

183047

Murmansk

191025

Saint Petersburg

192242

Saint Petersburg

195067

Saint Petersburg

196247

Saint Petersburg

197022

Saint Petersburg

198205

Saint Petersburg

199106

Saint Petersburg

200642

Craiova

214018

Smolensk

300736

Timișoara

308007

Belgorod

344022

Rostov-on-Don

350086

Krasnodar

400006

Cluj-Napoca

410028

Saratov

410053

Saratov

410054

Saratov

410169

Oradea

420012

Kazan'

420043

Kazan'

428007

Kaluga

430031

Baia

443070

Samara

454048

Chelyabinsk

454091

Chelyabinsk

540136

Târgu Mureş

610014

Kirov

620039

Yekaterinburg

620219

Yekaterinburg

630007

Novosibirsk

630051

Novosibirsk

630054

Novosibirsk

643012

Tomsk

650002

Kemerovo

656024

Barnaul

656045

Barnaul

664049

Irkutsk

700620

Iași

2570017

Viña del Mar

4781173

Temuco

7650568

Santiago

08401

Atlantic City

08240

Pomona

08876

Somerville

07901

Summit

44106-5072

Cleveland

05401

Colchester

C1181ACH

Buenos Aires

B7540DOL

Coronel Suarez, Buenos Aires

W3400AMZ

Corrientes

S2000DSV

Rosario, Santa Fe

T4000JCU

San Miguel de Tucumán

Qld 4064

Milton

Vic 3050

Parkville

Unknown

Randwick

Sofia

Osorno

Santiago

Tampere

Troisdorf

Ivano-Frankivsk

Vic 3121

Richmond

30150-221

Belo Horizonte - MG

18618-970

Botucatu

70710-905

Brasilia/DF

13083-970

Campinas

13059-740

Campinas, Sao Paulo

80030-001

Curitiba - PR

90620-001

Porto Alegre

Porto Alegre/RS

90880-480

Porto Alegre

41810-011

Salvador

Salvador/BA

40140-110

Salvador/BA

15090-000

São José Do Rio Preto- SP

01308-050

São Paulo

01323-903

São Paulo

04012-909

São Paulo

T6K4B3

Edmonton

B3H 3A7

Halifax

L8L 2X2

Hamilton

L8N 4A6

Hamilton

N2M1B2

Kitchener

K1H 8L6

Ottawa

P7B 6R4

Thunder Bay

H1T2M4

Montreal

N8X 5A6

Ontario

G1V 4G5

Québec

537 27

Chrudim

286 01

Čáslav

500 05

Hradec Králové

272 01

Kladno

697 33

Kyjov

460 63

Liberec

570 14

Litomyšl

771 11

Olomouc

703 84

Ostrava

305 99

Plzen - Bory

100 34

Prague

110 00

Prague

118 00

Prague

128 08

Prague

150 06

Prague

274 01

Slaný

386 29

Strakonice

415 29

Teplice

401 13

Ústí nad Labem

762 75

Zlín

669 02

Znojmo

DK-8200

Aarhus N

DK-2000

Frederiksberg

DK-2600

Glostrup Municipality

DK-6100

Haderslev

DK-2900

Hellerup

DK-3400

Hillerød

DK-2650

Hvidovre

DK-2400

København NV

DK-8600

Silkeborg

DK-4200

Slagelse

EE-10138

Tallinn

EE-13419

Tallinn

EE-51014

Tartu

FI-00290

Helsinki

FI-40620

Jyväskylä

FI-45750

Kouvola

FI-50100

Mikkeli

FI-28500

Pori

FI-20520

Turku

87 042

Limoges

30029 cedex 9

Nîmes

0144

Tbilisi

0159

Tbilisi

0183

Tbilisi

04600

Altenburg

01067

Dresden

01307

Dresden

H-4012

Debrecen

00168

Roma

LV-5417

Daugavpils

LV-3414

Liepāja

LV-1002

Riga

LV-1038

Riga

LV-4201

Valmiera

LT-62114

Alytus

LT-44320

Kaunas

LT-45130

Kaunas

LT-47144

Kaunas

LT-92231

Klaipėda

LT-92288

Klaipėda

LT-76231

Šiauliai

LT-04130

Vilnius

LT-08411

Vilnius

LT-10207

Vilnius

05154

Arequipa

CALLAO 2

Callao

01

Lima

Lima 11

Lima

LIMA 13

Lima

15-276

Bialystok

85-168

Bydgoszcz

85-681

Bydgoszcz

41-250

Czeladź

80-803

Gdansk

31-121

Krakow

31-913

Krakow

96-100

Skierniewice

39-400

Tarnobrzeg

01-138

Warsaw

02-097

Warsaw

87-800

Włocławek

020475

Bucharest

021659

Bucharest

022328

Bucharest

041915

Bucharest

949 01

Nitra

Gauteng 0084

Pretoria

08003

Barcelona

08036

Barcelona

08907

L'Hospitalet de Llobregat

08208

Sabadell

'08830

Sant Boi de Llobregat

03314

Orihuela

08023

Barcelona

08041

Barcelona

08221

Terrassa

01023

Kyiv

02091

Kyiv

02660

Kyiv

03680

Kyiv

04060

Kyiv

EC1M 6BQ

London

SE5 9RS

London

WC1E 6HX

London

M23 9LT

Manchester

NE7 7DN

Newcastle upon Tyne

RM7 0AG

Romford

UB1 3HW

Southall

Sponsors
All Listed Sponsors
lead

Portola Pharmaceuticals

INDUSTRY

NCT01583218 - Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) | Biotech Hunter | Biotech Hunter