Oral Rivaroxaban in Children With Venous Thrombosis

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 19, 2013

Primary Completion Date

September 1, 2016

Study Completion Date

September 1, 2016

Conditions
Venous Thrombosis
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.

DRUG

Active comparator

Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).

DRUG

Rivaroxaban (BAY59-7939) suspension

Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.

Trial Locations (59)

1090

Vienna

2145

Westmead

3010

Bern

3052

Parkville

4020

Linz

4056

Basel

4101

South Brisbane

6000

Lucerne

6020

Innsbruck

8032

Zurich

8036

Graz

9006

Sankt Gallen

10126

Turin

11040

New Hyde Park

13353

Berlin

16147

Genoa

19104

Philadelphia

20122

Milan

23298

Richmond

23538

Lübeck

27100

Pavia

31059

Toulouse

33076

Bordeaux

34295

Montpellier

35033

Rennes

35128

Padua

44093

Nantes

46202

Indianapolis

55404

Minneapolis

60590

Frankfurt am Main

60611

Chicago

70124

Bari

75015

Paris

75019

Paris

77030

Houston

79106

Freiburg im Breisgau

91054

Erlangen

3109601

Haifa

4920235

Petah Tikva

5262000

Ramat Gan

8410101

Beersheba

9112001

Jerusalem

72202-3500

Little Rock

90027-6089

Los Angeles

92868-3974

Orange

48201-2196

Detroit

44106-2602

Cleveland

43205-2696

Columbus

T6G 2B7

Edmonton

L8N 3Z5

Hamilton

K1H 8L1

Ottawa

M5G 1X8

Toronto

G1V 4G2

Québec

01307

Dresden

1081 HV

Amsterdam

Unknown

Amsterdam

6525 GA

Nijmegen

3015 GJ

Rotterdam

3584 CX

Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY