Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00439725
First received: February 23, 2007
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).


Condition Intervention Phase
Venous Thromboembolism
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.


Secondary Outcome Measures:
  • Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.

  • Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.

  • Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Major Bleeding [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: Yes ]
    All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.

  • Percentage of Participants With Clinically Relevant Bleeding [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: Yes ]
    All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported

  • Percentage of Participants With All Death [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: Yes ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)

  • Percentage of Participants With Other Vascular Events [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: Yes ]
    All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)


Other Outcome Measures:
  • Percentage of Participants With Death (PE) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Symptomatic Recurrent PE During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death.

  • Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With Recurrent DVT During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ] [ Designated as safety issue: No ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.


Enrollment: 1197
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 20 mg oral tablet once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Placebo Comparator: Placebo
Participants were to receive matching placebo oral tablet once daily
Drug: Placebo
Patients allocated to placebo will receive a matching placebo tablet once daily.

Detailed Description:

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Indication for VKA other than DVT and/or PE
  • Patients in whom anticoagulant treatment for their index PE or DVT should be continued
  • Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439725

  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles, California, United States, 90095
Redlands, California, United States, 92373
United States, Florida
Bay Pines, Florida, United States, 33744
Melbourne, Florida, United States, 32901
Miami, Florida, United States, 33136
Miami, Florida, United States, 33136-1096
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Louisiana
Covington, Louisiana, United States, 70433
United States, Maryland
Baltimore, Maryland, United States, 21215-5271
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New Mexico
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7035
Greensboro, North Carolina, United States, 27403
Greensboro, North Carolina, United States, 27401
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Corsicana, Texas, United States, 75110
San Antonio, Texas, United States, 78229
United States, Utah
Murray, Utah, United States, 84107
Salt Lake City, Utah, United States, 84132
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Fredericksburg, Virginia, United States, 22401
United States, Washington
Spokane, Washington, United States, 99204
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Gosford, New South Wales, Australia, 2250
Kogarah, New South Wales, Australia, 2217
Lismore, New South Wales, Australia, 2480
St Leonards, New South Wales, Australia, 2065
Sydney, New South Wales, Australia, 2139
Sydney, New South Wales, Australia, 2010
Sydney, New South Wales, Australia, 2031
Sydney, New South Wales, Australia, 2229
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Redcliffe, Queensland, Australia, 4020
Southport, Queensland, Australia, 4215
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5042
Adelaide, South Australia, Australia, 5011
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Clayton, Victoria, Australia, 3168
Geelong, Victoria, Australia, 3220
Melbourne, Victoria, Australia, 3135
Melbourne, Victoria, Australia, 3181
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Fremantle, Western Australia, Australia, 6160
Perth, Western Australia, Australia, 6000
Austria
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Feldkirch, Vorarlberg, Austria, 6807
Salzburg, Austria, 5020
Wien, Austria, 1140
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1200
Duffel, Belgium, 2570
Genk, Belgium, 3600
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Lier, Belgium, 2500
Namur, Belgium, 5000
Sint-Truiden, Belgium, 3800
Yvoir, Belgium, 5530
Zottegem, Belgium, 9620
Brazil
Uberaba, Minas Gerais, Brazil, 38010 380
Curitiba, Parana, Brazil, 80050-350
Londrina, Parana, Brazil, 86038440
Porto Alegre, Rio Grande do Sul, Brazil
Botucatu, Sao Paulo, Brazil, 18618 000
Sorocaba, Sao Paulo, Brazil, 18031-000
São Paulo, Sao Paulo, Brazil, 01323-001
São Paulo, Sao Paulo, Brazil, 04039-004
São Paulo, Sao Paulo, Brazil, 01509-900
Rio de Janeiro, Brazil
Sao Paulo, Brazil, 04023-061
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Toronto, Ontario, Canada, M6R 1B5
China, Guangdong
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
Harbin, Heilongjiang, China, 150086
China, Hubei
Wuhan, Hubei, China, 430022
China, Jiangsu
Suzhou, Jiangsu, China, 215004
China, Liaoning
Shenyang, Liaoning, China, 110016
China
Beijing, China, 100029
Beijing, China, 100853
Beijing, China, 100044
Beijing, China, 100037
Beijing, China, 100730
Beijing, China, 100038
Beijing, China, 100020
Shanghai, China, 200001
Shanghai, China, 200433
Shanghai, China, 200032
Czech Republic
Brno, Czech Republic, 65691
Karlovy Vary, Czech Republic, 360 00
Kladno, Czech Republic, 27259
Ostrava, Czech Republic, 728 80
Ostrava-Poruba, Czech Republic, 708 52
Prague 5, Czech Republic, 150 00
Praha 1, Czech Republic, 110 00
Praha 2, Czech Republic, 12800
Praha 4, Czech Republic, 140 21
Usti nad Lebem, Czech Republic, 401 13
Denmark
Aarhus C, Denmark, 8000
Braedstrup, Denmark, 8740
Frederiksberg, Denmark, 2000F
Hellerup, Denmark, 2900
Finland
Seinäjoki, Finland, 60220
France
Agen Cedex 9, France, 47923
Amiens, France, 80000
Angers Cedex 01, France, 49033
Arras, France, 62000
Bordeaux, France, 33075
Brest Cedex, France, 29609
Castelnau Le Lez, France, 34170
Clamart, France, 92141
Clermont Ferrand, France, 63000
Colombes, France, 92700
Creteil, France, 94000
Dijon, France, 21000
Grenoble, France, 38043
Grenoble, France, 38028
Lille Cedex, France, 59037
Limoges, France, 87042
Montpellier Cedex, France, 34295
Nantes, France, 44000
Nimes Cedex 9, France, 30029
Orthez, France, 64300
Paris, France, 75004
Paris, France, 75877
Paris, France, 75475
Paris Cedex 15, France, 75908
Pierre Benite, France, 69495
Roanne, France, 42328
Rouen Cedex, France, 76031
Saint Etienne, France, 42055
Strasbourg Cedex, France, 67091
Toulon, France, 83000
Toulouse, France, 31403
Tours, France, 37044
Valenciennes Cedex, France, 59322
Vandoeuvre Les Nancy, France, 54511
Vernon, France, 27200
Germany
Bruchsal, Baden-Württemberg, Germany, 76646
Heidelberg, Baden-Württemberg, Germany, 69115
Karlsbad, Baden-Württemberg, Germany, 76307
Mannheim, Baden-Württemberg, Germany, 68167
Neckargemünd, Baden-Württemberg, Germany, 69151
Tübingen, Baden-Württemberg, Germany, 72076
Augsburg, Bayern, Germany, 86156
München, Bayern, Germany, 80331
München, Bayern, Germany, 81377
Würzburg, Bayern, Germany, 97080
Darmstadt, Hessen, Germany, 64297
Frankfurt, Hessen, Germany, 60596
Gießen, Hessen, Germany, 35392
Wiesbaden, Hessen, Germany, 65183
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Hannover, Niedersachsen, Germany, 30625
Rotenburg, Niedersachsen, Germany, 27342
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Essen, Nordrhein-Westfalen, Germany, 45122
Paderborn, Nordrhein-Westfalen, Germany, 33098
Soest, Nordrhein-Westfalen, Germany, 59494
Witten, Nordrhein-Westfalen, Germany, 58455
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66424
Homburg, Saarland, Germany, 66421
Halle, Sachsen-Anhalt, Germany, 06120
Magdeburg, Sachsen-Anhalt, Germany, 39112
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04289
Berlin, Germany, 10713
Berlin, Germany, 12099
Hamburg, Germany, 20251
Hong Kong
Hong Kong, Hong Kong
Hungary
Budapest, Hungary, 1096
Budapest, Hungary, 1115
Debrecen, Hungary, 4032
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3526
Nyiregyhaza, Hungary, 4400
Szentes, Hungary, 6600
Szombathely, Hungary, 9700
India
Kochi, Kerala, India, 682026
Vellore, Kerala, India, 632004
Mumbai, Maharashtra, India, 400016
Mumbai, Maharashtra, India, 400022
Mumbai, Maharashtra, India, 400008
Hyderabad, India, 500082
Kolkata, India, 700029
New Delhi, India, 110060
Pune, India, 411001
Indonesia
Bandung, Indonesia, 40161
Jakarta, Indonesia, 10430
Medan, Indonesia, 20152
Semarang, Indonesia, 50241
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Beer Sheva, Israel, 84101
Haifa, Israel, 34362
Haifa, Israel, 31096
Haifa, Israel, 31048
Holon, Israel, 58100
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Rehovot, Israel, 76100
Safed, Israel, 13100
Tel Aviv, Israel, 64239
Italy
Bologna, Italy, 40138
Chieti, Italy, 66013
Milano, Italy, 20132
Milano, Italy, 20142
Napoli, Italy, 80131
Padova, Italy, 35128
Palermo, Italy, 90127
Parma, Italy, 43100
Pavia, Italy, 27100
Piacenza, Italy, 29100
Venezia, Italy, 30122
Korea, Republic of
Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 700721
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Daegu, Korea, Republic of, 705-718
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 120-752
Taegu, Korea, Republic of, 700-712
Malaysia
Selangor, Malaysia, 68000
Netherlands
Amsterdam, Netherlands, 1105 AZ
Arnhem, Netherlands, 6815 AD
Den Bosch, Netherlands, 5223 GZ
Dordrecht, Netherlands, 3318 AT
Enschede, Netherlands, 7511 JX
Groningen, Netherlands, 9713 GZ
Hoofddorp, Netherlands, 2134 TM
Maastricht, Netherlands, 6229 HX
Rotterdam, Netherlands, 3083 AN
Zwijndrecht, Netherlands, 3331 LZ
Zwolle, Netherlands, 8025 AB
New Zealand
Auckland, New Zealand, 1023
Auckland, New Zealand, 0622
Christchurch, New Zealand, 8011
Palmerston North, New Zealand, 4414
Wellington South, New Zealand, 6021
Norway
Fredrikstad, Norway, 1603
Oslo, Norway, 0407
Oslo, Norway, 0514
Rud, Norway, 1309
Philippines
Quezon City, Philippines, 0850
Quezon City, Philippines, 1102
Poland
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-168
Gdansk, Poland, 80-952
Katowice, Poland, 40-365
Krakow, Poland, 31-066
Lodz, Poland, 90-153
Lublin, Poland, 20-081
Poznan, Poland, 61-848
Poznan, Poland, 60-631
Torun, Poland, 87-100
Warszawa, Poland, 01-138
Warszawa, Poland, 02-097
Warszawa, Poland, 04-479
Wroclaw, Poland, 51-124
Wroclaw, Poland, 50-326
Singapore
Singapore, Singapore, 169608
Singapore, Singapore, 308433
South Africa
Cape Town, Cape, South Africa, 7500
Johannesburg, Gauteng, South Africa, 2157
Johannesburg, Gauteng, South Africa, 2191
Johannesburg, Gauteng, South Africa, 2193
Johannesburg, Gauteng, South Africa, 2132
Pretoria, Gauteng, South Africa, 0181
Pretoria, Gauteng, South Africa, 0084
Pretoria, Gauteng, South Africa, 0157
Roodepoort, Gauteng, South Africa, 1724
Cape Town, Western Cape, South Africa, 7460
Somerset West, Western Cape, South Africa, 7130
Worcester, Western Cape, South Africa, 6850
Spain
Terrassa, Barcelona, Spain, 08221
Alcorcón, Madrid, Spain, 28922
Fuenlabrada, Madrid, Spain, 28942
Xàtiva, Valencia, Spain, 46800
Barcelona, Spain, 08025
Barcelona, Spain, 08036
Girona, Spain, 17007
Madrid, Spain, 28034
Pamplona, Spain, 31008
Sweden
Borås, Sweden, 501 82
Göteborg, Sweden, 413 45
Göteborg, Sweden, 416 85
Jönköping, Sweden, 551 85
Sundsvall, Sweden, 851 86
Västervik, Sweden, 593 81
Switzerland
Bruderholz, Basel-Landschaft, Switzerland, 4101
Genéve 14, Genève 14, Switzerland, 1211
Chur, Graubünden, Switzerland, 7000
Brig, Valais, Switzerland, 3900
Lugano, Switzerland, 6903
Luzern, Switzerland, 6000
Zürich, Switzerland, 8091
Taiwan
Kaohsiung, Taiwan, 80756
Tainan, Taiwan, 704
Taipei, Taiwan, 11217
Taipei, Taiwan, 10002
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Pathumwan, Bangkok, Thailand, 10330
United Kingdom
Plymouth, Devon, United Kingdom, PL6 8DH
Chelmsford, Essex, United Kingdom, CM1 5ET
Romford, Essex, United Kingdom, RM7 0AG
Isleworth, London, United Kingdom, TW7 6AF
Edinburgh, Lothian, United Kingdom, EH16 4SA
Liverpool, Merseyside, United Kingdom, L7 8XP
London, United Kingdom, SE1 7EH
London, United Kingdom
London, United Kingdom, W1T 4EU
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Bayer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00439725     History of Changes
Other Study ID Numbers: 11899, 2006-004494-96
Study First Received: February 23, 2007
Results First Received: January 31, 2012
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014