Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

November 5, 2014

Primary Completion Date

September 16, 2021

Study Completion Date

September 16, 2021

Conditions
Deep Vein ThrombosisVenous Thromboembolism
Interventions
DRUG

Edoxaban low dose

Edoxaban low dose

DRUG

Edoxaban high dose

Edoxaban high dose

Trial Locations (35)

165

Bambino Gesu Hospital, Rome

1600

Hammoud Hospital University Medical Center, Saida

8035

Hospital Universitario Vall d'Hebron, Barcelona

14004

Hospital Universitario Reina Sofia, Córdoba

16148

Istituto Giannina Gaslini - UOSD Emostasi e Trombosi, Genova

19104

The Children's Hospital of Philadelphia, Philadelphia

22710

Duke University Medical Center (DUMC), Durham

28040

Hospital Clinico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

33604

CHU Bordeaux - Hopital Haut-Leveque, Pessac

34295

Hopital Arnaud de Villeneuve, Montpellier

35040

Ege University Medical Faculty - Department of Pediatric Hematology, Izmir

35127

A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova, Padua

38105

St. Jude Children's Research Hospital, Inc., Memphis

40202

University of Louisville ; Kosair Charities Pediatric Clincial Research Unit, Louisville

44106

University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital, Cleveland

46260

Indiana Hemophilia and Thrombosis Center, Indianapolis

53226

Children's Hospital of Wisconsin, Milwaukee

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

80045

University of Colorado Denver, Denver

90095

University of California, Los Angeles (UCLA), Los Angeles

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

141008

Christian Medical College and Hospital, Ludhiāna

395002

Nirmal Hospital Pvt. Ltd, Gujrāt

700017

Institute of Child Health, Kolkata

02903

Hasbro Children's Hospital, Providence

L8N3Z5

McMaster Children's Hospital, Hamilton

K1H8L1

Childrens Hospital of Eastern Ontario, Ottawa

BP 165191

Hotel Dieu De France, Beirut

01010

Hospital Universitario Araba, Vitoria-Gasteiz

LS1 3EB

Leeds General Infirmary, Leeds

LE3 9QP

Glenfield Hospital, Leicester

SE1 7EH

Guy's and St Thomas Hospital NHS Trust, London

SW3 6NP

Royal Brompton Hospital, London

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY