Trial Condition(s):
Venous thrombosis, Deep Vein Thrombosis
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients with Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Bayer Identifier:
11223
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients with acute symptomatic proximal deep vein thrombosis
Exclusion Criteria
- Contraindication to comparator drugs - Symptomatic Pulmonary embolism - Conditions with increased bleeding risk - Unstable patients with reduced life expectancy - Severe renal impairment - Impaired liver function - Strong CYP 3A4 inhibitors - Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics - NSAIDs with half-life > 17 hours
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Flinders Medical Centre Adelaide, Australia, 5042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ustredni vojenska nemocnice Praha Praha 6, Czech Republic, 169 02 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Bugyi Istvan Hospital Szentes, Hungary, 6600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Cayetano Heredia Lima, Peru, 31 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Clinical Research Unit - Box Hill Melbourne, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Medellín Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brüderkrankenhaus St. Josef Paderborn, Germany, 33098 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Arzobispo Loayza Lima Cercado, Peru, LIMA 1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital da Beneficiência Portuguesa São Paulo, Brazil, 01323-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Kladno Kladno, Czech Republic, 27259 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Circolo e Fond.Macchi Varese, Italy, 21100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUM - Hopital Hotel-Dieu Montreal, Canada, H2W 1T8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Investigación Clínica FOQUS Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Darmstadt Darmstadt, Germany, 64276 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario Monteluce Perugia, Italy, 06122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haematology Service, Canterbury Health Laboratories Christchurch, New Zealand, 8011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centralny Szpital Kliniczny AM Warszawa, Poland, 02-097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset Lund Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital e Maternidade Sao Luiz Sao Paulo, Brazil, 04544 000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Luzerner Kantonsspital Luzern, Switzerland, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thrombosis Unit Auckland, New Zealand, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St George Hospital Sydney, Australia, 2217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cardiodiagnostico S. A. Barranquilla, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mestska nemocnice Ostrava Ostrava, Czech Republic, 728 80 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapir Medical Center, Meir General Hospital Kfar Saba, Israel, 44281 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stichting het van Weel Bethesda Ziekenhuis DIRKSLAND, Netherlands, 3247 BW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szent Imre Hospital Budapest, Hungary, 1115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hadassah University Hospital Ein Kerem Jerusalem, Israel, 91120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Halmstad, Sweden, 301 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vergelegen Medi-Clinic Somerset West, South Africa, 7130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Clinical Research Unit - Maroondah Hospital Melbourne, Australia, 3135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Mary's Hospital Center Montreal, Canada, H3T 1M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny Olsztyn, Poland, 10-560 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Adelaide, Australia, 5011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamilton General Hospital Hamilton, Canada, L8L 2X2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis DEN BOSCH, Netherlands, 5211 RB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dos de Mayo Lima, Peru, 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wilhelminenspital der Stadt Wien Wien, Austria, 1171 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Perth Hospital Perth, Australia, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Franziskus-Krankenhaus Berlin, Germany, 10787 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Josep Trueta Girona, Spain, 17007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Shore Hospital Auckland, New Zealand, 0622 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Szpital Publiczny Bytom, Poland, 41-902 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pretoria Academic Hospital Ethics Committee Pretoria, South Africa, 0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Health Research Institute Ottawa, Canada, K1Y 4E9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vseobecná fakultni nemocnice Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Královské Vinohrady Praha 10, Czech Republic, 10034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de la Princesa Madrid, Spain, 28006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Centralny Szpital Kliniczny im. Gibinskiego Katowice, Poland, 40-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unitas Hospital Pretoria, South Africa, 0157 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pecs, Medical & Health Science Center Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Clinico Humanitas Rozzano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia Poznan, Poland, 61-833 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tiervlei Trial Centre Cape Town, South Africa, 7531 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Evang. Krankenhaus Königin Elisabeth, Herzberge Berlin, Germany, 10365 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wilgers Hospital Pretoria, South Africa, PRETORIA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny AM w Bialymstoku Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vinzenz Pallotti Hospital Bergisch Gladbach, Germany, 51429 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Centrum Haaglanden, Locatie Antoniushove LEIDSCHENDAM, Netherlands, 2262 BA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SRH Klinikum-Karlsbad-Langensteinbach gGmbH Karlsbad, Germany, 76307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Spectrum Twente, Locatie Ariensplein ENSCHEDE, Netherlands, 7511 JX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ Sint-Maarten DUFFEL, Belgium, 2570 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Plzen Plzen, Czech Republic, 30599 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Josefskrankenhaus Heidelberg, Germany, 69115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clalit Health Services - Haemek Medical Center Afula, Israel, 18101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Piacenza - Emilia Romagna Piacenza, Italy, 29100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of the Free State Bloemfontein, South Africa, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Barzilai Medical Center Ashkelon Ashkelon, Israel, 78306 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Avenue Cardiovascular Centre Melbourne, Australia, 3181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Humber River Regional Hospital Toronto, Canada, M3N 1N1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Paul's Hospital - Vancouver Vancouver, Canada, V6Z 1Y6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 4A6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Joseph's Health Centre Sudbury, Canada, P3E 3B5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Bay General Hospital North Bay, Canada, P1B 5A4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de Canarias La Laguna, Spain, 38320 | Status Completed | Contact Us: E-mail: [email protected]re.com Phone: Not Available |
Locations Ikazia Ziekenhuis ROTTERDAM, Netherlands, 3083 AN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Niguarda Ca' Granda Milano, Italy, 20162 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Sant Jaume de Olot Olot, Spain, 17800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Paolo Polo Universitario Milano, Italy, 20142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Rijnstate ARNHEM, Netherlands, 6815 AD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Giaccone Palermo, Italy, 90129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Centrum Haaglanden, Locatie Westeinde DEN HAAG, Netherlands, 2512 VA | Status Completed | Contact Us: E-mail: [email protected]m Phone: Not Available |
Locations AH Research Windsor, Canada, N8X 3V6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
ODIXa-DVTA prospective, randomized, multinational, multicenter, partially blinded, parallel-group, open-label active comparator controlled phase II dose finding and proof of principle trial.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- Response to treatment as determined by a Complete Compression Ultra sound (CCUS)Timeframe: 21 days
Secondary Outcome
- Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scanTimeframe: Day 21
- Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)Timeframe: Day 84
- Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)Timeframe: Day 1-84
- 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 periodTimeframe: Day 1-84
- 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 drugTimeframe: Day 1-114
Additional Information
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