Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke "MACSI"

Terminated

Phase 3 Results N/A

Update History

31 Jan '12
A location was updated in Oceanside.
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The overall status was removed for Research Center of Southern California.
A location was updated in Danbury.
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The overall status was removed for Associated Neurologists, P.C..
A location was updated in Savannah.
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The overall status was removed for Memorial Health University Medical Center.
A location was updated in Lexington.
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The overall status was removed for The University of Kentucky The Methodist Hospital.
A location was updated in Louisville.
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The overall status was removed for University of Louisville, Kentucky Neuroscience Research.
A location was updated in Boston.
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The overall status was removed for Tufts Medical Center.
A location was updated in Trenton.
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The overall status was removed for Capital Health Regional Medical Center Neuroscience Institute.
A location was updated in Charlotte.
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The overall status was removed for Presbitarian Hospital.
A location was updated in Youngstown.
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The overall status was removed for St. Elizabeth's Medical Center.
A location was updated in Tualatin.
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The overall status was removed for Legacy Meridian Park Medical Center.
A location was updated in Philadelphia.
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The overall status was removed for Thomas Jefferson University.
A location was updated in Houston.
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The overall status was removed for The Methodist Hospital.
A location was updated in Roanoke.
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The overall status was removed for Carilion Clinic.
A location was updated in Innsbruck.
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The overall status was removed for Medizinische Universität Innsbruck.
A location was updated in Klagenfurt.
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The overall status was removed for Landeskrankenhaus Klagenfurt.
A location was updated in Linz.
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The overall status was removed for Abt. Neurologie und Psychiatrie.
A location was updated in St. Pölten.
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The overall status was removed for LKH St. Pölten Department of Neurology.
A location was updated in Belo Horizonte.
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The overall status was removed for Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia.
A location was updated in Porto Alegre.
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The overall status was removed for Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital Moinhos de Vento.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital Mãe de Deus.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Clinicas de Porto Alegre.
A location was updated in Ribeirão Preto.
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The overall status was removed for Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos.
A location was updated in San Paulo.
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The overall status was removed for Unifesp.
A location was updated in Santa Catarina.
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The overall status was removed for Hospital São José de Joinville.
A location was updated in Sao Paulo.
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The overall status was removed for Hospital Santa Marcelina.
A location was updated in Hamilton.
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The overall status was removed for Hamilton Health Sciences Centre.
A location was updated in Edmonton.
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The overall status was removed for Grey Nun's Community Hospital.
A location was updated in Edmonton.
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The overall status was removed for University of Alberta Hospital.
A location was updated in Hamilton.
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The overall status was removed for Hamilton Health Sciences Centre.
A location was updated in Kingston.
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The overall status was removed for Kingston General Hospital.
A location was updated in Lethbridge.
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The overall status was removed for Chinook Regional Hospital.
A location was updated in Quebec.
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The overall status was removed for CHA- Hôpital de l'Enfant-Jésus.
A location was updated in Brno.
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The overall status was removed for University Hospital Brno.
A location was updated in Hradec Kralove.
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The overall status was removed for University Hospital Hradec Kralove, Clinic of Neurology.
A location was updated in Jihlava.
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The overall status was removed for Hospital Jihlava Clinic of Neurology.
A location was updated in Ostrava.
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The overall status was removed for Hospital Vítkovice Clinic of Neurology.
A location was updated in Pardubice.
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The overall status was removed for County Hospital Pardubice Clinic of Neurology.
A location was updated in Prague.
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The overall status was removed for University Hospital Kralovske Vinohrady.
A location was updated in Prague.
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The overall status was removed for University Hospital Motol Clinic of Neurology.
A location was updated in Prague.
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The overall status was removed for Clinic of Neurology, Stroke Center, Charles University.
A location was updated in Besancon.
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The overall status was removed for CHU Jean Minjoz Besançon.
A location was updated in Bordeaux.
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The overall status was removed for Hopital Pellegrin-Tripode.
A location was updated in Créteil.
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The overall status was removed for CHU Henri Mondor.
A location was updated in Montpellier.
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The overall status was removed for Hopital Gui de Chauliac.
A location was updated in Paris.
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The overall status was removed for Hôpital Lariboisière - Service Neurologie.
A location was updated in Paris.
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The overall status was removed for Hôpital Bichat.
A location was updated in Perpignan.
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The overall status was removed for Hôpital Saint Jean.
A location was updated in Bad Neustadt / Saale.
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The overall status was removed for Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG.
A location was updated in Bergisch Gladbach.
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The overall status was removed for Marien-Krankenhaus gGmbH, Abteilung für Neurologie.
A location was updated in Berlin.
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The overall status was removed for Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit.
A location was updated in Berlin.
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The overall status was removed for DRK Kliniken Berlin, Klinik fuer Neurologie.
A location was updated in Bremen.
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The overall status was removed for Klinikum Bremen-Mitte.
A location was updated in Bremerhaven.
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The overall status was removed for Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik.
A location was updated in Chemnitz.
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The overall status was removed for Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie.
A location was updated in Erfurt.
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The overall status was removed for Helios Klinikum Erfurt GmbH.
A location was updated in Erlangen.
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The overall status was removed for Universitätsklinikum Erlangen, Neurologische klinik.
A location was updated in Essen.
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The overall status was removed for Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie.
A location was updated in Freiburg.
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The overall status was removed for Neurologische Universitätsklinik Freiburg, Neurozentrum.
A location was updated in Fulda.
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The overall status was removed for Klinikum Fulda, Neurologische Klinik.
A location was updated in Gelsenkirchen.
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The overall status was removed for Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie.
A location was updated in Gottingen.
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The overall status was removed for Georg-August-Universitat Gottingen Neurologische Klinik.
A location was updated in Grifswald.
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The overall status was removed for Ernst Moritz Arndt University.
A location was updated in Hamburg.
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The overall status was removed for Askepios Klinik Heidberg.
A location was updated in Hamburg.
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The overall status was removed for Askepios Klinik Altona.
A location was updated in Koln.
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The overall status was removed for Klinikum Köln Merheim, Department of Neurology.
A location was updated in Leipzig.
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The overall status was removed for Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie.
A location was updated in Magdeburg.
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The overall status was removed for Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik.
A location was updated in Mainz.
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The overall status was removed for Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie.
A location was updated in Minden.
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The overall status was removed for Klinikum 1 Minden, Neurologische Klinik.
A location was updated in Rostock.
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The overall status was removed for Universität Rostock Chefarzt Abteilung Neurologie.
A location was updated in Teupitz.
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The overall status was removed for ASKLEPIOS Fachklinikum Teupitz.
A location was updated in Trier.
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The overall status was removed for Krankenhaus der Bramherzigen Brüder.
A location was updated in Ulm.
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The overall status was removed for Universitätsklinikum Ulm, Abteilung für Neurologie im RKU.
A location was updated in Zwickau.
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The overall status was removed for Heinrich Braun Klinikum Zwickau.
A location was updated in Budapest.
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The overall status was removed for Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ.
A location was updated in Budapest.
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The overall status was removed for Állami Egészségügyi Központ.
A location was updated in Debrecen.
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The overall status was removed for University of Debrecen, Medical and Health Science Center.
A location was updated in Debrecen.
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The overall status was removed for Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft..
A location was updated in Gyor.
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The overall status was removed for Aladár Petz County Teaching Hospital.
A location was updated in Kistarcsa.
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The overall status was removed for PM Flór Ferenc County Hospital.
A location was updated in Miskolc.
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The overall status was removed for Borsod-Abaúj-Zemplén County Hospital Miskolc.
A location was updated in Pecs.
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The overall status was removed for Pecsi Tudomanyegyetem Klinikai Kozpont.
A location was updated in Zalaegerszeg.
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The overall status was removed for Zala Megyei Kórház.
A location was updated in Haifa.
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The overall status was removed for Bnai Zion Medical Center.
A location was updated in Holon.
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The overall status was removed for Neurological Dept. Edith Wolfson Medical Center.
A location was updated in Kfar Saba.
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The overall status was removed for Meir Medical Center.
A location was updated in Tel Aviv.
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The overall status was removed for Sourasky Medical Center.
A location was updated in Tel Hashomer.
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The overall status was removed for Chaim Sheba Medical Center.
A location was updated in Aosta.
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The overall status was removed for Ospedale Regionale Valle d'Aosta.
A location was updated in Cagliari.
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The overall status was removed for Dipartimento di Neuroscienze, Ospedale di Brotzu.
A location was updated in Lombardia.
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The overall status was removed for Ospedale di Circolo di Varese.
A location was updated in Milano.
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The overall status was removed for Istituto Scientifico San Raffaele - Stroke Unit.
A location was updated in Pavia.
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The overall status was removed for Istituto Neurologico C. Mondino.
A location was updated in Perugia.
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The overall status was removed for Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit.
A location was updated in Piacenza.
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The overall status was removed for Presidio Ospedaliero di Piacenza.
A location was updated in Rome.
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The overall status was removed for Azienda Ospedaliera Sant'Andrea, Stroke Unit.
A location was updated in Rome.
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The overall status was removed for Istituto Patologia Generale U.C.S.C.
A location was updated in Rome.
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The overall status was removed for Università di Roma "La Sapienza" - Stroke Unit.
A location was updated in Rome.
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The overall status was removed for U.O.C. Stroke Unit.
A location was updated in Udine.
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The overall status was removed for Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit.
A location was updated in Busan.
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The overall status was removed for Inje University BUSAN Paik Hospital.
A location was updated in Busan.
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The overall status was removed for Dong-A Medical Center.
A location was updated in Goyang.
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The overall status was removed for Inje University ILSAN Paik Hospital.
A location was updated in Gwangju.
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The overall status was removed for Chonnam National University Hospital.
A location was updated in Incheon.
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The overall status was removed for Inha University Hospital.
A location was updated in Seongnam.
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The overall status was removed for Seoul National University Bundang Hospital.
A location was updated in Seoul.
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The overall status was removed for Severance Hospital.
A location was updated in Seoul.
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The overall status was removed for Asan medical center.
A location was updated in Seoul.
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The overall status was removed for The Catholic University of Korea Seoul St. Mary's hospital.
A location was updated in Eindhoven.
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The overall status was removed for Catharina Ziekenhuis Neurologie.
A location was updated in Enschede.
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The overall status was removed for Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie.
A location was updated in Heerlen.
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The overall status was removed for Atrium MC Parkstad.
A location was updated in Zwolle.
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The overall status was removed for Isala Klinieken Ploikliniek Neurologie.
A location was updated in Gdansk.
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The overall status was removed for Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus.
A location was updated in Lublin.
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The overall status was removed for Medical University of Lublin, Department of Neurology, Stroke Unit.
A location was updated in Sandomierz.
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The overall status was removed for Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu.
A location was updated in Skarżysko-Kamienna.
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The overall status was removed for Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej.
A location was updated in Tychy.
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The overall status was removed for Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego.
A location was updated in Warsaw.
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The overall status was removed for Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym.
A location was updated in Warsaw.
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The overall status was removed for Wojskowy Instytut Medyczny, Oddział Neurologii.
A location was updated in Warsaw.
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The overall status was removed for Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii.
A location was updated in Warsaw.
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The overall status was removed for Medical University of Warsaw, Department of Neurology.
A location was updated in Amadora.
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The overall status was removed for Hospital Professor Doutor Fernando Fonseca, EPE.
A location was updated in Coimbra.
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The overall status was removed for Centro Hospitalar de Coimbra EPE.
A location was updated in Coimbra.
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The overall status was removed for Hospitais da Universidadde de Coimbra, EPE.
A location was updated in Lisboa.
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The overall status was removed for Centro de Estudos Egas Moniz - Hospital de Santa Maria.
A location was updated in Santa Maria da Feira.
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The overall status was removed for Hospital de São Sebastião, EPE.
A location was updated in Martin.
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The overall status was removed for Neurology Clinic, Faculty Hospital in Martin.
A location was updated in Nitra.
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The overall status was removed for University Hospital Nitra.
A location was updated in Spisska Nova Ves.
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The overall status was removed for Hospital un Poliklinic.
A location was updated in Trnava.
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The overall status was removed for Faculty Hospital Trnava.
A location was updated in Zilina.
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The overall status was removed for Neurology dept.,Hospital Zilina.
A location was updated in Bloemfontein.
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The overall status was removed for Fichmed.
A location was updated in Cape Town.
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The overall status was removed for Constantiaberg Medi-clinic.
A location was updated in Gauteng.
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The overall status was removed for Union Hospital.
A location was updated in Western Cape.
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The overall status was removed for Helderberg Research Institute.
A location was updated in Western Cape.
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The overall status was removed for Triervlei Trial Centre.
A location was updated in Worcester.
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The overall status was removed for Clinical Projects Research.
A location was updated in Albacete.
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The overall status was removed for Hospital Universitario de Albacete.
A location was updated in Barcelona.
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The overall status was removed for Hospital Germans Triasy Pujol.
A location was updated in Barcelona.
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The overall status was removed for Hospital Del Mar.
A location was updated in Barcelona.
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The overall status was removed for Hospital Vall D'hebron.
A location was updated in Barcelona.
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The overall status was removed for Hospital De La Santa Ta Creu i Sant Pau.
A location was updated in Madrid.
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The overall status was removed for Hospital Universitario La Paz.
A location was updated in Madrid.
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The overall status was removed for Hospital La Princesa.
A location was updated in Madrid.
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The overall status was removed for Hospital Universitario Clinico San Carlos.
A location was updated in Madrid.
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The overall status was removed for Hospital Ramon y Cajal.
A location was updated in Madrid.
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The overall status was removed for Hospital Gregorio Maranon.
A location was updated in Santiago de Compostela.
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The overall status was removed for Hospital Clinico Universitario de Santiago.
A location was updated in Valencia.
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The overall status was removed for Consorcio Hospital General Universitario Valencia.
A location was updated in Valladolid.
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The overall status was removed for Hospital Clinico Universitario De Valladolid.
A location was updated in Basel.
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The overall status was removed for Universitätsspital Basel, Neurologie.
A location was updated in Zurich.
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The overall status was removed for Universitätsspital Zürich, Klinik für Neurologie.
31 Dec '11
The description was updated.
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This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d for 4 consecutive days, in acute ischemic stroke patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility will be performed after Day 90 (or last available observation) primary endpoint data have been collected on about 45% of subjects planned to be enrolled. Clinical trial material (CTM) will be administered within 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the accumulating safety data periodically and will oversee the interim futility analysis.
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This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d for 4 consecutive days, in acute ischemic stroke patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility will be performed after Day 90 (or last available observation) primary endpoint data have been collected on 50% of subjects planned to be enrolled. Enrollment will be stratified on a one to one basis into two time-to-treatment tiers: 0- 4.5 hours, and >4.5 - 9 hours after stroke onset. Clinical trial material (CTM) will be administered within 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the accumulating safety data periodically and will oversee the interim futility analysis.
A location was updated in Bradenton.
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The overall status was updated to "Withdrawn" at Bradenton Research Center.
A location was updated in Daytona Beach.
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The overall status was updated to "Withdrawn" at Halifax Medical Center.
A location was updated in Lawrenceville.
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The overall status was updated to "Withdrawn" at Neuroscience Research Institute/Dekalb Neurology.
A location was updated in Edison.
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The overall status was updated to "Withdrawn" at JFK Medical Center.
A location was updated in Albuquerque.
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The overall status was updated to "Withdrawn" at University of New Mexico.
A location was updated in Asheville.
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The overall status was updated to "Withdrawn" at Mission Health System Research Institute.
A location was updated in Cleveland.
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The overall status was updated to "Withdrawn" at MetroHealth Medical Center.
A location was updated in Allentown.
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The overall status was updated to "Withdrawn" at Lehigh Valley Hospital.
A location was updated in Nashville.
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The overall status was updated to "Withdrawn" at Vanderbilt Medical Center.
A location was updated in Ceara.
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The overall status was updated to "Withdrawn" at Hospital Geral de Fortaleza.
A location was updated in Corner Brook.
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The overall status was updated to "Withdrawn" at Western Memorial Health Clinic.
A location was updated in Toronto.
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The overall status was updated to "Withdrawn" at St. Michael's Hospital.
A location was updated in Chomutov.
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The overall status was updated to "Withdrawn" at Hospital Chomutov, Department of Neurology.
A location was updated in Toulouse.
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The overall status was updated to "Withdrawn" at Hôpital Purpan.
A location was updated in Berlin.
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The overall status was updated to "Withdrawn" at Charite - Universitatsmedizin Berlin / Campus Charite Mitte, Klinik und Poliklinik fur Neurologie.
A location was updated in Dortmund.
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The overall status was updated to "Withdrawn" at Klinikum Dortmund, Neurologische Klinik.
A location was updated in Dusseldorf.
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The overall status was updated to "Withdrawn" at Heinrich Heine Universität, Neurologische Klinik.
A location was updated in Hannover.
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The overall status was updated to "Withdrawn" at Medizinische Hochschule Hannover, Klinik für Neurologie.
A location was updated in Herford.
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The overall status was updated to "Withdrawn" at Klinikum Herford.
A location was updated in Osnabruck.
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The overall status was updated to "Withdrawn" at Klinikum Osnabrück GmbH, Abteilung Neurologie.
A location was updated in Wuerselen.
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The overall status was updated to "Withdrawn" at Medizinisches Zentrum Kreis Aachen GmbH, Klinik für Neurologie.
A location was updated in Ashkelon.
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The overall status was updated to "Withdrawn" at Barzilai Medical Center.
A location was updated in Czestochowa.
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The overall status was updated to "Withdrawn" at Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny.
A location was updated in Bratislava.
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The overall status was updated to "Withdrawn" at 1st Department of Neurology, University Hospital, Comenius University.
A location was updated in Girona.
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The overall status was updated to "Withdrawn" at Hospital Josep Trueta.
A location was updated in Aarau.
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The overall status was updated to "Withdrawn" at Kantonsspital Aarau.