Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

PHASE2CompletedINTERVENTIONAL
Enrollment

543

Participants

Timeline

Start Date

December 31, 2004

Study Completion Date

December 31, 2005

Conditions
Venous Thromboembolism
Interventions
DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 20 mg once daily (od) for 12 weeks

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 30 mg od for 12 weeks

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 40 mg od for 12 weeks

DRUG

(LMW) Heparin + Vitamin K Antagonist

Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks

Trial Locations (78)

2000

Frederiksberg

2065

Sydney

2132

Johannesburg

2157

Johannesburg

2191

Johannesburg

2193

Johannesburg

2217

Sydney

2605

Canberra

3128

Melbourne

3168

Melbourne

3181

Melbourne

4102

Brisbane

8000

Aarhus

8740

Brædstrup

10034

Prague

13100

Safed

18101

Afula

20122

Milan

20132

Milan

20142

Milan

22401

Fredericksburg

27100

Pavia

29609

Brest

30122

Venezia

31048

Haifa

31096

Haifa

34295

Montpellier

34362

Haifa

35128

Padua

38043

Grenoble

42055

Saint-Etienne

42100

Reggio Emilia

44281

Kfar Saba

49100

Petah Tikva

52621

Tel Litwinsky

58100

Holon

59322

Valenciennes

64239

Tel Aviv

75475

Paris

75908

Paris

78306

Ashkelon

87131

Albuquerque

98122

Seattle

87108-4763

Albuquerque

27599-7065

Chapel Hill

80050-350

Curitiba

90470 340

Porto Alegre

01323-001

São Paulo

18031-000

Sorocaba

T6G 2B7

Edmonton

B3H 3A7

Halifax

N6A 5A5

London

500 05

Hradec Králové

360 66

Karlovy Vary

708 52

Ostrava

323 33

Pilsen

150 06

Prague

401 13

Ústí nad Labem

3818 ES

Amersfoort

1081 HV

Amsterdam

1105 AZ

Amsterdam

6815 AD

Arnhem

9713 GZ

Groningen

2134 TM

Hoofddorp

6229 HX

Maastricht

6162 BG

Sittard-geleen

8025 AB

Zwolle

02-097

Warsaw

85-168

Bydgoszcz

01-138

Warsaw

50-367

Wroclaw

51-124

Wroclaw

Unknown

Johannesburg

416 85

Gothenburg

551 85

Jönköping

118 83

Stockholm

171 76

Stockholm

593 81

Västervik

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Bayer

INDUSTRY