Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001083-43 | EudraCT Number | ||
| ODIXa-DVT | Other Identifier | Company Internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xarelto (Rivaroxaban, BAY59-7939) | Drug | 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment as determined by a Complete Compression Ultra sound (CCUS) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
- Patients with acute symptomatic proximal deep vein thrombosis
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney | New South Wales | 2217 | Australia | |||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Xarelto (Rivaroxaban, BAY59-7939) | Drug | 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) | Drug | 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) | Drug | 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 | Drug | 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 |
|
| 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 |
| Adelaide |
| South Australia |
| 5011 |
| Australia |
| Adelaide | South Australia | 5042 | Australia |
| Melbourne | Victoria | 3128 | Australia |
| Melbourne | Victoria | 3135 | Australia |
| Melbourne | Victoria | 3181 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Graz | Styria | 8036 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1171 | Austria |
| Duffel | 2570 | Belgium |
| Leuven | 3000 | Belgium |
| São Paulo | São Paulo | 01323-001 | Brazil |
| São Paulo | São Paulo | 04544 000 | Brazil |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Greater Sudbury | Ontario | P3E 3B5 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton | Ontario | L8N 4A6 | Canada |
| North Bay | Ontario | P1B 5A4 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto | Ontario | M3N 1N1 | Canada |
| Windsor | Ontario | N8X 3V6 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Montreal | Quebec | H3T 1M5 | Canada |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Medellín | Colombia |
| Brno | 656 91 | Czechia |
| Kladno | 27259 | Czechia |
| Ostrava | 728 80 | Czechia |
| Pilsen | 30599 | Czechia |
| Prague | 10034 | Czechia |
| Prague | 12808 | Czechia |
| Prague | 169 02 | Czechia |
| Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Karlsbad | Baden-Wurttemberg | 76307 | Germany |
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
| München | Bavaria | 80336 | Germany |
| Darmstadt | Hesse | 64276 | Germany |
| Bergisch Gladbach | North Rhine-Westphalia | 51429 | Germany |
| Paderborn | North Rhine-Westphalia | 33098 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Berlin | 10365 | Germany |
| Berlin | 10787 | Germany |
| Budapest | 1115 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7624 | Hungary |
| Szentes | 6600 | Hungary |
| Afula | 18101 | Israel |
| Ashkelon | 78306 | Israel |
| Haifa | 31096 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91120 | Israel |
| Kfar Saba | 44281 | Israel |
| Tel Aviv | 64239 | Israel |
| Rozzano | Milano | 20089 | Italy |
| Bologna | 40138 | Italy |
| Milan | 20142 | Italy |
| Milan | 20162 | Italy |
| Padova | 35128 | Italy |
| Palermo | 90129 | Italy |
| Perugia | 06122 | Italy |
| Piacenza | 29100 | Italy |
| Reggio Emilia | 42100 | Italy |
| Varese | 21100 | Italy |
| 's-Hertogenbosch | 5211 RB | Netherlands |
| Arnhem | 6815 AD | Netherlands |
| Dirksland | 3247 BW | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Leidschendam | 2262 BA | Netherlands |
| Rotterdam | 3083 AN | Netherlands |
| The Hague | 2512 VA | Netherlands |
| Auckland | 0622 | New Zealand |
| Auckland | 1023 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Lima | 01 | Peru |
| Lima | 31 | Peru |
| Lima Cercado | LIMA 1 | Peru |
| Bialystok | 15-276 | Poland |
| Bytom | 41-902 | Poland |
| Gdansk | 80-952 | Poland |
| Katowice | 40-752 | Poland |
| Lublin | 20-718 | Poland |
| Olsztyn | 10-560 | Poland |
| Poznan | 61-833 | Poland |
| Warsaw | 02-097 | Poland |
| Bloemfontein | Freestate | 9300 | South Africa |
| Pretoria | Gauteng | 0084 | South Africa |
| Pretoria | Gauteng | 0157 | South Africa |
| Pretoria | Gauteng | PRETORIA | South Africa |
| Cape Town | Western Cape | 7531 | South Africa |
| Somerset West | Western Cape | 7130 | South Africa |
| Badalona | Barcelona | 08916 | Spain |
| Olot | Girona | 17800 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Barcelona | 08036 | Spain |
| Girona | 17007 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28007 | Spain |
| Valencia | 46010 | Spain |
| Gothenburg | 413 45 | Sweden |
| Gothenburg | 416 85 | Sweden |
| Halmstad | 301 85 | Sweden |
| Jönköping | 551 85 | Sweden |
| Lund | 221 85 | Sweden |
| Basel | 4031 | Switzerland |
| Bern | 3010 | Switzerland |
| Lucerne | 6000 | Switzerland |
| Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D016769 | Embolism and Thrombosis |
| D011655 | Pulmonary Embolism |
| D004617 | Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided