Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

November 4, 2015

Primary Completion Date

May 22, 2018

Study Completion Date

May 22, 2018

Conditions
Thrombosis
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939

Single dose of reconstituted rivaroxaban granules

Trial Locations (21)

1094

University of Semmelweis/ Semmelweis Egyetem, Budapest

3000

UZ Leuven Gasthuisberg, Leuven

10126

A.O.U. Città della Salute e della Scienza di Torino, Turin

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20520

Turun yliopistollinen keskussairaala, kantasairaala, Turku

28007

Hospital General Universitario Gregorio Marañón, Madrid

28204

Carolinas Healthcare System, Charlotte

34059

Hôpital Arnaud de Villeneuve - Montpellier, Montpellier

35128

A.O. di Padova, Padua

46202

Riley Hospital For Children, Indianapolis

72202

Arkansas Children's Hospital, Little Rock

75015

Hopital Necker les enfants malades - Paris, Paris

94609

Children's Hospital Oakland, Oakland

43205-2696

Nationwide Children's Hospital, Columbus

T6G 2B7

University of Alberta Hospital, Edmonton

L8N 3Z5

McMaster Children's Hospital, Hamilton

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

00029

HUS Lastenklinikka, HUS

08950

Hospital de Sant Joan de Déu, Esplugues de Llobregat

08035

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY