Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

PHASE2CompletedINTERVENTIONAL
Enrollment

613

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

October 31, 2005

Study Completion Date

October 31, 2005

Conditions
Venous ThrombosisDeep Vein Thrombosis
Interventions
DRUG

Xarelto (Rivaroxaban, BAY59-7939)

10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Enoxaparin/Vitamin K-Antagonist

Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days

Trial Locations (110)

31

Lima

1023

Auckland

1090

Vienna

1115

Budapest

1171

Vienna

2217

Sydney

2570

Duffel

3000

Leuven

3010

Bern

3128

Melbourne

3135

Melbourne

3181

Melbourne

4031

Basel

4032

Debrecen

5011

Adelaide

5042

Adelaide

6000

Perth

Lucerne

6600

Szentes

7130

Somerset West

7531

Cape Town

7624

Pécs

8011

Christchurch

8036

Graz

8091

Zurich

9300

Bloemfontein

10034

Prague

10365

Berlin

10787

Berlin

12808

Prague

17007

Girona

17800

Olot

18101

Afula

20089

Rozzano

20142

Milan

20162

Milan

21100

Varese

27259

Kladno

28006

Madrid

28007

Madrid

29100

Piacenza

30599

Pilsen

31096

Haifa

33098

Paderborn

35128

Padua

38320

San Cristóbal de La Laguna

40138

Bologna

42100

Reggio Emilia

44281

Kfar Saba

46010

Valencia

51429

Bergisch Gladbach

58100

Holon

64239

Tel Aviv

64276

Darmstadt

68167

Mannheim

69115

Heidelberg

76307

Karlsbad

78306

Ashkelon

80336

München

90129

Palermo

91120

Jerusalem

01323-001

São Paulo

04544 000

São Paulo

V6Z 1Y6

Vancouver

P3E 3B5

Greater Sudbury

L8L 2X2

Hamilton

L8N 4A6

Hamilton

P1B 5A4

North Bay

L1G 2B9

Oshawa

K1Y 4E9

Ottawa

M3N 1N1

Toronto

N8X 3V6

Windsor

H2W 1T8

Montreal

H3T 1M5

Montreal

Unknown

Barranquilla

Bogotá

Medellín

656 91

Brno

728 80

Ostrava

169 02

Prague

01307

Dresden

06122

Perugia

5211 RB

's-Hertogenbosch

6815 AD

Arnhem

3247 BW

Dirksland

7511 JX

Enschede

2262 BA

Leidschendam

3083 AN

Rotterdam

2512 VA

The Hague

0622

Auckland

01

Lima

LIMA 1

Lima Cercado

15-276

Bialystok

41-902

Bytom

80-952

Gdansk

40-752

Katowice

20-718

Lublin

10-560

Olsztyn

61-833

Poznan

02-097

Warsaw

0084

Pretoria

0157

Pretoria

PRETORIA

Pretoria

08916

Badalona

08036

Barcelona

413 45

Gothenburg

416 85

Gothenburg

301 85

Halmstad

551 85

Jönköping

221 85

Lund

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY