Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
NCT ID: NCT00839163
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
613 participants
INTERVENTIONAL
2004-03-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Xarelto (Rivaroxaban, BAY59-7939)
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Arm 2
Xarelto (Rivaroxaban, BAY59-7939)
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Arm 3
Xarelto (Rivaroxaban, BAY59-7939)
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Arm 4
Xarelto (Rivaroxaban, BAY59-7939)
40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Arm 5
Enoxaparin/Vitamin K-Antagonist
Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days
Interventions
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Xarelto (Rivaroxaban, BAY59-7939)
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Xarelto (Rivaroxaban, BAY59-7939)
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Xarelto (Rivaroxaban, BAY59-7939)
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Xarelto (Rivaroxaban, BAY59-7939)
40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Enoxaparin/Vitamin K-Antagonist
Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Graz, Styria, Austria
Vienna, , Austria
Vienna, , Austria
Duffel, , Belgium
Leuven, , Belgium
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Vancouver, British Columbia, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
North Bay, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Barranquilla, , Colombia
Bogotá, , Colombia
Medellín, , Colombia
Brno, , Czechia
Kladno, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Heidelberg, Baden-Wurttemberg, Germany
Karlsbad, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Darmstadt, Hesse, Germany
Bergisch Gladbach, North Rhine-Westphalia, Germany
Paderborn, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Berlin, , Germany
Berlin, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Szentes, , Hungary
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Tel Aviv, , Israel
Rozzano, Milano, Italy
Bologna, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Perugia, , Italy
Piacenza, , Italy
Reggio Emilia, , Italy
Varese, , Italy
's-Hertogenbosch, , Netherlands
Arnhem, , Netherlands
Dirksland, , Netherlands
Enschede, , Netherlands
Leidschendam, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Lima, , Peru
Lima, , Peru
Lima Cercado, , Peru
Bialystok, , Poland
Bytom, , Poland
Gdansk, , Poland
Katowice, , Poland
Lublin, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Bloemfontein, Freestate, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Badalona, Barcelona, Spain
Olot, Girona, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Gothenburg, , Sweden
Halmstad, , Sweden
Jönköping, , Sweden
Lund, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Lucerne, , Switzerland
Zurich, , Switzerland
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2004-001083-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ODIXa-DVT
Identifier Type: OTHER
Identifier Source: secondary_id
11223
Identifier Type: -
Identifier Source: org_study_id
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