check_circleStudy Completed
Venous Thrombosis, Deep Vein Thrombosis
Bayer Identifier:
11223
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients with Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Trial purpose
The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
613Trial Dates
March 2004 - October 2005Phase
Phase 2Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Flinders Medical Centre | Adelaide, 5042, Australia |
Completed | Universitätsspital Zürich | Zürich, 8091, Switzerland |
Completed | Ustredni vojenska nemocnice Praha | Praha 6, 169 02, Czech Republic |
Completed | Dr Bugyi Istvan Hospital | Szentes, 6600, Hungary |
Completed | Rambam Medical Center | Haifa, 31096, Israel |
Completed | Hospital Nacional Cayetano Heredia | Lima, 31, Peru |
Completed | Eastern Clinical Research Unit - Box Hill | Melbourne, 3128, Australia |
Completed | Clínica Medellín | Medellín, Colombia |
Completed | Brüderkrankenhaus St. Josef | Paderborn, 33098, Germany |
Completed | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Completed | Hospital Nacional Arzobispo Loayza | Lima Cercado, LIMA 1, Peru |
Completed | Hospital da Beneficiência Portuguesa | São Paulo, 01323-001, Brazil |
Completed | Hospital Kladno | Kladno, 27259, Czech Republic |
Completed | A.O. Osp Circolo e Fond.Macchi | Varese, 21100, Italy |
Completed | CHUM - Hopital Hotel-Dieu | Montreal, H2W 1T8, Canada |
Completed | Centro de Investigación Clínica FOQUS | Bogotá, Colombia |
Completed | Klinikum Darmstadt | Darmstadt, 64276, Germany |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Policlinico Universitario Monteluce | Perugia, 06122, Italy |
Completed | Haematology Service, Canterbury Health Laboratories | Christchurch, 8011, New Zealand |
Completed | Centralny Szpital Kliniczny AM | Warszawa, 02-097, Poland |
Completed | Universitetssjukhuset Lund | Lund, 221 85, Sweden |
Completed | Hospital e Maternidade Sao Luiz | Sao Paulo, 04544 000, Brazil |
Completed | Luzerner Kantonsspital | Luzern, 6000, Switzerland |
Completed | Fakultni nemocnice u sv. Anny | Brno, 656 91, Czech Republic |
Completed | Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel |
Completed | Thrombosis Unit | Auckland, 1023, New Zealand |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | St George Hospital | Sydney, 2217, Australia |
Completed | Cardiodiagnostico S. A. | Barranquilla, Colombia |
Completed | Mestska nemocnice Ostrava | Ostrava, 728 80, Czech Republic |
Completed | Sapir Medical Center, Meir General Hospital | Kfar Saba, 44281, Israel |
Completed | Stichting het van Weel Bethesda Ziekenhuis | DIRKSLAND, 3247 BW, Netherlands |
Completed | Inselspital Bern | Bern, 3010, Switzerland |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Completed | Szent Imre Hospital | Budapest, 1115, Hungary |
Completed | Hadassah University Hospital Ein Kerem | Jerusalem, 91120, Israel |
Completed | A.O.U. Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy |
Completed | Länssjukhuset | Halmstad, 301 85, Sweden |
Completed | Vergelegen Medi-Clinic | Somerset West, 7130, South Africa |
Completed | Eastern Clinical Research Unit - Maroondah Hospital | Melbourne, 3135, Australia |
Completed | St. Mary's Hospital Center | Montreal, H3T 1M5, Canada |
Completed | Hospital General Universitario Gregorio Marañón | Madrid, 28007, Spain |
Completed | Wojewodzki Szpital Specjalistyczny | Olsztyn, 10-560, Poland |
Completed | Queen Elizabeth Hospital | Adelaide, 5011, Australia |
Completed | Hamilton General Hospital | Hamilton, L8L 2X2, Canada |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Edith Wolfson Medical Center | Holon, 58100, Israel |
Completed | Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis | DEN BOSCH, 5211 RB, Netherlands |
Completed | Hospital Dos de Mayo | Lima, 01, Peru |
Completed | Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ | Lublin, 20-718, Poland |
Completed | SU/Östra | Göteborg, 416 85, Sweden |
Completed | Wilhelminenspital der Stadt Wien | Wien, 1171, Austria |
Completed | Royal Perth Hospital | Perth, 6000, Australia |
Completed | Franziskus-Krankenhaus | Berlin, 10787, Germany |
Completed | Hospital Josep Trueta | Girona, 17007, Spain |
Completed | North Shore Hospital | Auckland, 0622, New Zealand |
Completed | Samodzielny Szpital Publiczny | Bytom, 41-902, Poland |
Completed | Länssjukhuset Ryhov | Jönköping, 551 85, Sweden |
Completed | Pretoria Academic Hospital Ethics Committee | Pretoria, 0084, South Africa |
Completed | Ottawa Health Research Institute | Ottawa, K1Y 4E9, Canada |
Completed | Vseobecná fakultni nemocnice | Praha 2, 12808, Czech Republic |
Completed | Fakultni nemocnice Královské Vinohrady | Praha 10, 10034, Czech Republic |
Completed | Hospital Universitario de la Princesa | Madrid, 28006, Spain |
Completed | A.O. di Padova | Padova, 35128, Italy |
Completed | SP Centralny Szpital Kliniczny im. Gibinskiego | Katowice, 40-752, Poland |
Completed | Unitas Hospital | Pretoria, 0157, South Africa |
Completed | University of Pecs, Medical & Health Science Center | Pecs, 7624, Hungary |
Completed | IRCCS Ist Clinico Humanitas | Rozzano, 20089, Italy |
Completed | Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia | Poznan, 61-833, Poland |
Completed | Tiervlei Trial Centre | Cape Town, 7531, South Africa |
Completed | Evang. Krankenhaus Königin Elisabeth, Herzberge | Berlin, 10365, Germany |
Completed | Wilgers Hospital | Pretoria, PRETORIA, South Africa |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | SP Szpital Kliniczny AM w Bialymstoku | Bialystok, 15-276, Poland |
Completed | Vinzenz Pallotti Hospital | Bergisch Gladbach, 51429, Germany |
Completed | Medisch Centrum Haaglanden, Locatie Antoniushove | LEIDSCHENDAM, 2262 BA, Netherlands |
Completed | SRH Klinikum-Karlsbad-Langensteinbach gGmbH | Karlsbad, 76307, Germany |
Completed | Medisch Spectrum Twente, Locatie Ariensplein | ENSCHEDE, 7511 JX, Netherlands |
Completed | AZ Sint-Maarten | DUFFEL, 2570, Belgium |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Completed | Fakultni nemocnice Plzen | Plzen, 30599, Czech Republic |
Completed | St. Josefskrankenhaus | Heidelberg, 69115, Germany |
Completed | Clalit Health Services - Haemek Medical Center | Afula, 18101, Israel |
Completed | AUSL Piacenza - Emilia Romagna | Piacenza, 29100, Italy |
Completed | University of the Free State | Bloemfontein, 9300, South Africa |
Completed | Klinikum Mannheim gGmbH | Mannheim, 68167, Germany |
Completed | University of Debrecen Medical&Health Science Center | Debrecen, 4032, Hungary |
Completed | The Barzilai Medical Center Ashkelon | Ashkelon, 78306, Israel |
Completed | The Avenue Cardiovascular Centre | Melbourne, 3181, Australia |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Humber River Regional Hospital | Toronto, M3N 1N1, Canada |
Completed | Klinikum Innenstadt der Ludwigs-Maximilians-Universität | München, 80336, Germany |
Completed | St. Paul's Hospital - Vancouver | Vancouver, V6Z 1Y6, Canada |
Completed | Lakeridge Health-Oshawa | Oshawa, L1G 2B9, Canada |
Completed | St. Joseph's Healthcare - Hamilton | Hamilton, L8N 4A6, Canada |
Completed | St. Joseph's Health Centre | Sudbury, P3E 3B5, Canada |
Completed | North Bay General Hospital | North Bay, P1B 5A4, Canada |
Completed | Hospital Universitario de Canarias | La Laguna, 38320, Spain |
Completed | Ikazia Ziekenhuis | ROTTERDAM, 3083 AN, Netherlands |
Completed | A.O. Osp Niguarda Ca' Granda | Milano, 20162, Italy |
Completed | Uniwersyteckie Centrum Kliniczne | Gdansk, 80-952, Poland |
Completed | Hospital Sant Jaume de Olot | Olot, 17800, Spain |
Completed | A.O. San Paolo Polo Universitario | Milano, 20142, Italy |
Completed | Ziekenhuis Rijnstate | ARNHEM, 6815 AD, Netherlands |
Completed | A.O.U. Policlinico Giaccone | Palermo, 90129, Italy |
Completed | Medisch Centrum Haaglanden, Locatie Westeinde | DEN HAAG, 2512 VA, Netherlands |
Completed | AH Research | Windsor, N8X 3V6, Canada |
Primary Outcome
- Response to treatment as determined by a Complete Compression Ultra sound (CCUS)date_rangeTime Frame:21 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scandate_rangeTime Frame:Day 21enhanced_encryptionNoSafety Issue:
- Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)date_rangeTime Frame:Day 84enhanced_encryptionNoSafety Issue:
- Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)date_rangeTime Frame:Day 1-84enhanced_encryptionNoSafety Issue:
- Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment perioddate_rangeTime Frame:Day 1-84enhanced_encryptionNoSafety Issue:
- Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drugdate_rangeTime Frame:Day 1-114enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
5Additional Information
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