check_circleStudy Completed

Venous Thrombosis, Deep Vein Thrombosis

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

Both

Age

18 Years
  • - Patients with acute symptomatic proximal deep vein thrombosis
  • - 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
613
Trial Dates
March 2004 - October 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Flinders Medical CentreAdelaide, 5042, Australia
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Ustredni vojenska nemocnice PrahaPraha 6, 169 02, Czech Republic
Completed
Dr Bugyi Istvan HospitalSzentes, 6600, Hungary
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
Hospital Nacional Cayetano HerediaLima, 31, Peru
Completed
Eastern Clinical Research Unit - Box HillMelbourne, 3128, Australia
Completed
Clínica MedellínMedellín, Colombia
Completed
Brüderkrankenhaus St. JosefPaderborn, 33098, Germany
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
Hospital Nacional Arzobispo LoayzaLima Cercado, LIMA 1, Peru
Completed
Hospital da Beneficiência PortuguesaSão Paulo, 01323-001, Brazil
Completed
Hospital KladnoKladno, 27259, Czech Republic
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Completed
CHUM - Hopital Hotel-DieuMontreal, H2W 1T8, Canada
Completed
Centro de Investigación Clínica FOQUSBogotá, Colombia
Completed
Klinikum DarmstadtDarmstadt, 64276, Germany
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Policlinico Universitario MontelucePerugia, 06122, Italy
Completed
Haematology Service, Canterbury Health LaboratoriesChristchurch, 8011, New Zealand
Completed
Centralny Szpital Kliniczny AMWarszawa, 02-097, Poland
Completed
Universitetssjukhuset LundLund, 221 85, Sweden
Completed
Hospital e Maternidade Sao LuizSao Paulo, 04544 000, Brazil
Completed
Luzerner KantonsspitalLuzern, 6000, Switzerland
Completed
Fakultni nemocnice u sv. AnnyBrno, 656 91, Czech Republic
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Thrombosis UnitAuckland, 1023, New Zealand
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
St George HospitalSydney, 2217, Australia
Completed
Cardiodiagnostico S. A.Barranquilla, Colombia
Completed
Mestska nemocnice OstravaOstrava, 728 80, Czech Republic
Completed
Sapir Medical Center, Meir General HospitalKfar Saba, 44281, Israel
Completed
Stichting het van Weel Bethesda ZiekenhuisDIRKSLAND, 3247 BW, Netherlands
Completed
Inselspital BernBern, 3010, Switzerland
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Szent Imre HospitalBudapest, 1115, Hungary
Completed
Hadassah University Hospital Ein KeremJerusalem, 91120, Israel
Completed
A.O.U. Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
LänssjukhusetHalmstad, 301 85, Sweden
Completed
Vergelegen Medi-ClinicSomerset West, 7130, South Africa
Completed
Eastern Clinical Research Unit - Maroondah HospitalMelbourne, 3135, Australia
Completed
St. Mary's Hospital CenterMontreal, H3T 1M5, Canada
Completed
Hospital General Universitario Gregorio MarañónMadrid, 28007, Spain
Completed
Wojewodzki Szpital SpecjalistycznyOlsztyn, 10-560, Poland
Completed
Queen Elizabeth HospitalAdelaide, 5011, Australia
Completed
Hamilton General HospitalHamilton, L8L 2X2, Canada
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Completed
Jeroen Bosch Ziekenhuis, lokatie Groot ZiekengasthuisDEN BOSCH, 5211 RB, Netherlands
Completed
Hospital Dos de MayoLima, 01, Peru
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Wilhelminenspital der Stadt WienWien, 1171, Austria
Completed
Royal Perth HospitalPerth, 6000, Australia
Completed
Franziskus-KrankenhausBerlin, 10787, Germany
Completed
Hospital Josep TruetaGirona, 17007, Spain
Completed
North Shore HospitalAuckland, 0622, New Zealand
Completed
Samodzielny Szpital PublicznyBytom, 41-902, Poland
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Pretoria Academic Hospital Ethics CommitteePretoria, 0084, South Africa
Completed
Ottawa Health Research InstituteOttawa, K1Y 4E9, Canada
Completed
Vseobecná fakultni nemocnicePraha 2, 12808, Czech Republic
Completed
Fakultni nemocnice Královské VinohradyPraha 10, 10034, Czech Republic
Completed
Hospital Universitario de la PrincesaMadrid, 28006, Spain
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
SP Centralny Szpital Kliniczny im. GibinskiegoKatowice, 40-752, Poland
Completed
Unitas HospitalPretoria, 0157, South Africa
Completed
University of Pecs, Medical & Health Science CenterPecs, 7624, Hungary
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
Wielospecjalistyczny Szpital Miejski im. Jozefa StrusiaPoznan, 61-833, Poland
Completed
Tiervlei Trial CentreCape Town, 7531, South Africa
Completed
Evang. Krankenhaus Königin Elisabeth, HerzbergeBerlin, 10365, Germany
Completed
Wilgers HospitalPretoria, PRETORIA, South Africa
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
Vinzenz Pallotti HospitalBergisch Gladbach, 51429, Germany
Completed
Medisch Centrum Haaglanden, Locatie AntoniushoveLEIDSCHENDAM, 2262 BA, Netherlands
Completed
SRH Klinikum-Karlsbad-Langensteinbach gGmbHKarlsbad, 76307, Germany
Completed
Medisch Spectrum Twente, Locatie ArienspleinENSCHEDE, 7511 JX, Netherlands
Completed
AZ Sint-MaartenDUFFEL, 2570, Belgium
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Fakultni nemocnice PlzenPlzen, 30599, Czech Republic
Completed
St. JosefskrankenhausHeidelberg, 69115, Germany
Completed
Clalit Health Services - Haemek Medical CenterAfula, 18101, Israel
Completed
AUSL Piacenza - Emilia RomagnaPiacenza, 29100, Italy
Completed
University of the Free StateBloemfontein, 9300, South Africa
Completed
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Completed
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Completed
The Barzilai Medical Center AshkelonAshkelon, 78306, Israel
Completed
The Avenue Cardiovascular CentreMelbourne, 3181, Australia
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Humber River Regional HospitalToronto, M3N 1N1, Canada
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Completed
St. Paul's Hospital - VancouverVancouver, V6Z 1Y6, Canada
Completed
Lakeridge Health-OshawaOshawa, L1G 2B9, Canada
Completed
St. Joseph's Healthcare - HamiltonHamilton, L8N 4A6, Canada
Completed
St. Joseph's Health CentreSudbury, P3E 3B5, Canada
Completed
North Bay General HospitalNorth Bay, P1B 5A4, Canada
Completed
Hospital Universitario de CanariasLa Laguna, 38320, Spain
Completed
Ikazia ZiekenhuisROTTERDAM, 3083 AN, Netherlands
Completed
A.O. Osp Niguarda Ca' GrandaMilano, 20162, Italy
Completed
Uniwersyteckie Centrum KliniczneGdansk, 80-952, Poland
Completed
Hospital Sant Jaume de OlotOlot, 17800, Spain
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Completed
Ziekenhuis RijnstateARNHEM, 6815 AD, Netherlands
Completed
A.O.U. Policlinico GiacconePalermo, 90129, Italy
Completed
Medisch Centrum Haaglanden, Locatie WesteindeDEN HAAG, 2512 VA, Netherlands
Completed
AH ResearchWindsor, N8X 3V6, Canada

Primary Outcome

  • Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
    date_rangeTime Frame:
    Day 21
    enhanced_encryption
    Safety Issue:
    No
  • Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
    date_rangeTime Frame:
    Day 84
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
    date_rangeTime Frame:
    Day 1-84
    enhanced_encryption
    Safety Issue:
    No
  • 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 period
    date_rangeTime Frame:
    Day 1-84
    enhanced_encryption
    Safety Issue:
    No
  • 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 drug
    date_rangeTime Frame:
    Day 1-114
    enhanced_encryption
    Safety Issue:
    No

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