Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

June 23, 2016

Primary Completion Date

August 5, 2019

Study Completion Date

August 5, 2019

Conditions
Pulmonary EmbolismThrombotic Disease
Interventions
DRUG

DS-1040b

Single, continuous intravenous infusion over 12 to 24 hours (depending on cohort)

DRUG

Placebo

Single, continuous intravenous infusion of 0.9% sodium chloride over 12 to 24 hours

DRUG

Enoxaparin

Subcutaneous injection 1 mg/kg twice daily

Trial Locations (46)

1070

Universite Libre de Bruxelles (ULB) - Hopital Erasme, Brussels

1090

Medical University of Vienna, Vienna

1200

Cliniques Universitaires Saint-Luc, Brussels

3000

University Hospital Leuven, Leuven

6020

Medical University Innsbruck, Innsbruck

8036

Medical University Graz, Graz

10016

NYU Radiology Associate, New York

10461

Jacobi Medical Center, The Bronx

17007

Hospital Universitario, Girona

17011

Capital Area Research, Camp Hill

17475

Universitaetsmedizin Greifswald, Greifswald

19140

Temple University Hospital, Philadelphia

20089

Humanitas Research Hospital, Rozzano

21100

Ospedale di Circolo, Varese

27710

Duke University Medical Center (DUMC), Durham

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

29609

CHU de Brest - Hopital de la Cavale Blanche, Brest

34239

Intercoastal Medical Group, Sarasota

36608

Pulmonary Associates of Mobile, Mobile

38700

CHU de Grenoble, La Tronche

39120

Universitatsklinikum Magdeburg, Magdeburg

40536

University of Kentucky Medical Center, Lexington

41014

Hospital Virgen del Rocío, Seville

42055

CHU St Etienne - Hopital Nord, Saint-Etienne

44195

The Cleveland Clinic Foundation, Cleveland

55905

Mayo Clinic - Rochester, Rochester

59701

Mercury Street Medical, Butte

60126

AOU Ospedali Riuniti di Ancona, Ancona

60611

Northwestern Memorial Hospital, Chicago

63000

CHU Gabriel Montpied Clermont-Ferrand, Clermont-Ferrand

67091

Hopital Civil de Strasbourg, Strasbourg

75017

Hopital Europeen Georges Pompidou, Paris

81675

Klinikum rechts der Isar, Technische Universität München, München

90211

Cedars-Sinai Medical Center, Beverly Hills

92103

University of California, San Diego (UCSD) Medical Center, San Diego

02114

Massachusetts General Hospital, Boston

01067

Staedtisches Klinikum Dresden-Friedrichstadt, Dresden

01307

Universitaetsklinikum Dresden, Dresden

06129

Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia, Perugia

1815 JD

Noordwest Ziekenhuisgroep, Alkmaar

1105 AZ

Academisch Medisch Centrum, Amsterdam

3318 AT

Albert Schweitzer Hospital, Dordrecht

2333 ZA

Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC), Leiden

2545 AA

HagaZiekenhuis, The Hague

3584 CX

UMC Utrecht, Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY