Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

August 13, 2019

Study Completion Date

August 13, 2019

Conditions
Acute Ischemic StrokeThrombotic Disease
Interventions
DRUG

DS-1040b

DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period

DRUG

Placebo

0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period

Trial Locations (55)

2065

Royal North Shore Hospital, Sydney

3050

Royal Melbourne Hospital, Parkville

3168

Monash Health, Clayton

5000

Royal Adelaide Hospital Neurology Dept., Adelaide

10029

Icahn School Medicine at Mount Sinai, New York

17027

Ospedaliero di Albenga - Pietra Ligure Dept Neurology, Pietra Ligure

17033

Penn State Milton S. Hershey Medical Center, Hershey

25000

CHRU Besançon - Hôpital Jean Minjoz, Besançon

27710

Duke University Health System, Durham

29121

Ospedale Guglielmo da Saliceto Via Taverna, Piacenza

29203

Palmetto Health, USC School of Medicine, Columbia

33000

Hôpital Pellegrin - CHU Bordeaux, Bordeaux

36604

University of South Alabama USA Health System, Mobile

37121

Ospedale Borgo Trento, Verona

37403

Chattanooga Center for Neurologic Research, Chattanooga

40202

University of Louisville, Louisville

40536

University of Kentucky Chandler Medical Center, Lexington

43210

OSU - Wexner Medical Center, Columbus

48202

Henry Ford Health System, Detroit

56126

Azienda Ospedaliero Universitaria, Pisa

59037

CHRU Lille - Hôpital Roger Salengro, Lille

60612

Rush University Medical Center, Chicago

77030

Houston Methodist, Houston

80909

UC Health Memorial Hospital, Colorado Springs

90024

UCLA Medical Center Stroke Network, Los Angeles

97239

Oregon Health Sciences University Hospital, Portland

08820

JFK Neuroscience Institute, Edison

Unknown

St. Annes University Hospital, Brno

Vitkovicka nemocnice a.s. Zaluzanskeho, Ostrava Vitkovice

Universittsklinikum Essen AR Klinik fr Neurologie, Essen

Klinikum der Johann Wolfgang Goethe-Universitat, Frankfurt am Main

Svet zdravia a.s.,Vseobecna nemocnica Rimavska Sobota, Rimavská Sobota

NsP Spisska Nova Ves, Spišská Nová Ves

Pusan National University Hospital, Busan

Seoul National University Bundang Hospital, Seongnam-si

Samsung Medical Center, Seoul

Hospital de la santa creu i sant pau C, Barcelona

Vall d'Hebron Hospital, Barcelona

Hospital Universitario La Paz, Madrid

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

Hospital Universitario Virgen Macarena, Seville

Hospital Virgen del Rocio, Seville

Hospital Clinico Universitario de Valladolid, Valladolid

Hospital Clinico Universitario Lozano Blesa de Zaragoza, Zaragoza

Chang Gung Memorial Hospital-Linkou Branch, Taoyuan District

China Medical University Hospital, Taichung

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

University College Hospitals NHS Foundation Trust, London

Queen Elizabeth University Hospital, Glasgow

Salford Royal Hospital, Salford

Royal Stoke University Hospital, Stoke-on-Trent

04600

Klinikum Altenburger Land, Altenburg

06018

Ospedale di Citta di Castello, Città di Castello

06024

Ospedale di Branca Largo Unita d'Italia, Gubbio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY