Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.
3 other identifiers
interventional
613
18 countries
107
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2004
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 6, 2009
CompletedFirst Posted
Study publicly available on registry
February 9, 2009
CompletedSeptember 7, 2023
October 1, 2014
1.6 years
February 6, 2009
September 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
21 days
Secondary Outcomes (5)
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Day 21
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Day 84
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
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 period
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 drug
Day 1-114
Study Arms (5)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
EXPERIMENTALArm 5
ACTIVE COMPARATORInterventions
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
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
You may qualify if:
- \- Patients with acute symptomatic proximal deep vein thrombosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (110)
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Sydney, New South Wales, 2217, Australia
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Adelaide, South Australia, 5011, Australia
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Adelaide, South Australia, 5042, Australia
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Melbourne, Victoria, 3128, Australia
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Melbourne, Victoria, 3135, Australia
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Melbourne, Victoria, 3181, Australia
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Perth, Western Australia, 6000, Australia
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Graz, Styria, 8036, Austria
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Vienna, 1090, Austria
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Vienna, 1171, Austria
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Duffel, 2570, Belgium
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Leuven, 3000, Belgium
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São Paulo, São Paulo, 01323-001, Brazil
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São Paulo, São Paulo, 04544 000, Brazil
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Greater Sudbury, Ontario, P3E 3B5, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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North Bay, Ontario, P1B 5A4, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Toronto, Ontario, M3N 1N1, Canada
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Windsor, Ontario, N8X 3V6, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Barranquilla, Colombia
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Bogotá, Colombia
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Medellín, Colombia
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Brno, 656 91, Czechia
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Kladno, 27259, Czechia
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Ostrava, 728 80, Czechia
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Pilsen, 30599, Czechia
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Prague, 10034, Czechia
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Prague, 12808, Czechia
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Prague, 169 02, Czechia
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Heidelberg, Baden-Wurttemberg, 69115, Germany
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Karlsbad, Baden-Wurttemberg, 76307, Germany
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Mannheim, Baden-Wurttemberg, 68167, Germany
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München, Bavaria, 80336, Germany
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Darmstadt, Hesse, 64276, Germany
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Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany
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Paderborn, North Rhine-Westphalia, 33098, Germany
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Dresden, Saxony, 01307, Germany
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Berlin, 10365, Germany
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Berlin, 10787, Germany
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Budapest, 1115, Hungary
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Debrecen, 4032, Hungary
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Pécs, 7624, Hungary
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Szentes, 6600, Hungary
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Afula, 18101, Israel
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Ashkelon, 78306, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Tel Aviv, 64239, Israel
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Rozzano, Milano, 20089, Italy
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Bologna, 40138, Italy
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Milan, 20142, Italy
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Milan, 20162, Italy
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Padua, 35128, Italy
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Palermo, 90129, Italy
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Perugia, 06122, Italy
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Piacenza, 29100, Italy
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Reggio Emilia, 42100, Italy
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Varese, 21100, Italy
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's-Hertogenbosch, 5211 RB, Netherlands
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Arnhem, 6815 AD, Netherlands
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Dirksland, 3247 BW, Netherlands
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Enschede, 7511 JX, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Rotterdam, 3083 AN, Netherlands
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The Hague, 2512 VA, Netherlands
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Auckland, 0622, New Zealand
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Auckland, 1023, New Zealand
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Christchurch, 8011, New Zealand
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Lima, 01, Peru
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Lima, 31, Peru
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Lima Cercado, LIMA 1, Peru
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Bialystok, 15-276, Poland
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Bytom, 41-902, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-752, Poland
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Lublin, 20-718, Poland
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Olsztyn, 10-560, Poland
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Poznan, 61-833, Poland
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Warsaw, 02-097, Poland
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Bloemfontein, Freestate, 9300, South Africa
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Pretoria, Gauteng, 0084, South Africa
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Pretoria, Gauteng, 0157, South Africa
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Pretoria, Gauteng, PRETORIA, South Africa
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Cape Town, Western Cape, 7531, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Badalona, Barcelona, 08916, Spain
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Olot, Girona, 17800, Spain
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San Cristóbal de La Laguna, Tenerife, 38320, Spain
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Barcelona, 08036, Spain
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Girona, 17007, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Valencia, 46010, Spain
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Gothenburg, 413 45, Sweden
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Gothenburg, 416 85, Sweden
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Halmstad, 301 85, Sweden
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Jönköping, 551 85, Sweden
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Lund, 221 85, Sweden
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Lucerne, 6000, Switzerland
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Zurich, 8091, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2009
First Posted
February 9, 2009
Study Start
March 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
September 7, 2023
Record last verified: 2014-10