Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Venous ThrombosisPediatrics
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

Trial Locations (36)

12

Crumlin

1090

Vienna

3052

Parkville

4020

Linz

4029

Brisbane

4056

Basel

10126

Torino

11040

New Hyde Park

15224

Pittsburgh

16147

Genova

19104

Philadelphia

20122

Milan

23538

Lübeck

27100

Pavia

27514

Chapel Hill

27710

Durham

31059

Toulouse

32610

Gainesville

33701

St. Petersburg

34059

Montpellier

46202

Indianapolis

46260

Indianapolis

60611

Chicago

63003

Clermont-Ferrand

75015

Paris

90095

Los Angeles

92868

Orange

5262000

Tel Litwinsky

9112001

Jerusalem

72202-3500

Little Rock

90027-6089

Los Angeles

48201-2196

Detroit

44106-6007

Cleveland

T6G 1C9

Edmonton

L8N 3Z5

Hamilton

M5G 1X8

Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY