Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT 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:
NCT00440193
First received: February 23, 2007
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).


Condition Intervention Phase
Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Enoxaparin followed by VKA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

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: 3-, 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.


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: 3-, 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 deaths), results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment [ Time Frame: 3-, 6- or 12-month study treatment period ] [ Designated as safety issue: No ]
    Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.

  • Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment [ Time Frame: 3-, 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 Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) [ Time Frame: 3-, 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. Clinically relevant bleeding included major bleeding (overt bleeding associated with 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) 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 activities of daily life.

  • Percentage of Participants With All Deaths [ Time Frame: 3-, 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.

  • Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) [ Time Frame: 3-, 6- or 12-month study treatment period ] [ Designated as safety issue: Yes ]
    All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.


Other Outcome Measures:
  • Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment [ Time Frame: 3-, 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 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: Up to 30 days after the 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 the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period [ Time Frame: Up to 30 days after the 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 an Event for Net Clinical Benefit 1 During Observational Period [ Time Frame: Up to 30 days after the last intake of study medication ] [ Designated as safety issue: No ]
    Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.

  • Percentage of Participants With Recurrent DVT During Observational Period [ Time Frame: Up to 30 days after the 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, venography, results/films/images of confirmatory testing, and/or case summaries.

  • Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period [ Time Frame: Up to 30 days after the 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, 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.


Enrollment: 3449
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Active Comparator: Enoxaparin/VKA
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
Drug: Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

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. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.

  Eligibility

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

Inclusion Criteria:

  • Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
  • Other indication for VKA than DVT and/or PE
  • The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
  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: NCT00440193

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Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Redlands, California, United States, 92373
United States, Florida
Bay Pines, Florida, United States, 33744
Miami, Florida, United States, 33136-1096
Miami, Florida, United States, 33136
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
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New Mexico
Albuquerque, New Mexico, United States, 87108-4763
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
Camp Hill, Pennsylvania, United States, 17011
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, 84157
Salt Lake City, Utah, United States, 84132
United States, Virginia
Fredericksburg, Virginia, United States, 22401
United States, Washington
Spokane, Washington, United States, 99204
Tacoma, Washington, United States, 98405
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
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, 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
Woodville South, 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
Australia, Western Australia
Fremantle, Western Australia, Australia, 6160
Perth, Western Australia, Australia, 6000
Austria
Graz, Steiermark, Austria, 8036
Feldkirch, Vorarlberg, Austria, 6807
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Wien, Austria, 1140
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1200
Bruxelles - Brussel, Belgium, 1070
Duffel, Belgium, 2570
Genk, Belgium, 3600
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Lier, Belgium, 2500
Namur, Belgium, 5000
Yvoir, Belgium, 5530
Zottegem, Belgium, 9620
Brazil
Uberaba, Minas Gerais, Brazil, 38010 380
Curitiba, Parana, Brazil, 80050-350
Londrina, Parana, Brazil, 86038440
Botucatu, Sao Paulo, Brazil, 18618 000
Sorocaba, Sao Paulo, Brazil, 18031-000
São Paulo, Sao Paulo, Brazil, 04039-004
Sao Paulo, SP, Brazil, 04023-061
Sao Paulo, SP, Brazil, 01509-900
São Paulo, SP, Brazil, 01323-001
Rio de Janeiro, Brazil
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
London, Ontario, Canada, N6A 4G5
Ottawa, Ontario, Canada, K1Y 4E9
Toronto, Ontario, Canada, M6R 1B5
Toronto, Ontario, Canada, M4N 3M5
China, Guangdong
Guangzhou, Guangdong, China, 510000
Guangzhou, Guangdong, China, 510120
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, Zhejiang
Hangzhou, Zhejiang, China, 310016
China
Beijing, China, 100730
Beijing, China, 100038
Beijing, China, 100853
Beijing, China, 100044
Beijing, China, 100020
Beijing, China, 100029
Beijing, China, 100037
Shanghai, China, 200032
Shanghai, China, 200433
Shanghai, China, 200001
Czech Republic
Karlovy Vary, Czech Republic, 360 00
Kladno, Czech Republic, 27259
Ostrava, Czech Republic, 728 80
Ostrava-Poruba, Czech Republic, 708 52
Prague, Czech Republic, 140 21
Prague 5, Czech Republic, 150 00
Praha 1, Czech Republic, 110 00
Praha 2, Czech Republic, 12800
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
Besancon, France, 25000
Bordeaux, France, 33000
Brest Cedex, France, 29609
Castelnau Le Lez, France, 34170
Clamart, France, 92141
Clermont Ferrand, France, 63000
Colombes Cedex, France, 92701
Creteil, France, 94000
Dijon, France, 21000
Grenoble, France, 38043
Grenoble, France, 38028
Lille Cedex, France, 59037
Limoges, France, 87042
Metz-tessy, France, 74370
Montpellier Cedex, France, 34295
Nantes, France, 44000
Nice, France, 06002
Nimes Cedex 9, France, 30029
Orthez, France, 64300
Paris, France, 75015
Paris, France, 75877
Paris, France, 75004
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, 81377
München, Bayern, Germany, 80331
Würzburg, Bayern, Germany, 97080
Darmstadt, Hessen, Germany, 64297
Frankfurt, Hessen, Germany, 60596
Frankfurt, Hessen, Germany, 60590
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, 66421
Homburg, Saarland, Germany, 66424
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
Wanchai, Hong Kong
Hungary
Budapest, Hungary, 1115
Budapest, Hungary, 1096
Debrecen, Hungary, 4032
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3526
Szentes, Hungary, 6600
Szombathely, Hungary, 9700
India
Kochi, Kerala, India, 682026
Mumbai, Maharashtra, India, 400016
Hyderabad, India, 500082
Kolkata, India, 700029
New Delhi, India, 110060
Pune, India, 411001
Indonesia
Bandung, Indonesia, 40161
Jakarta, Indonesia, 10430
Jakarta, Indonesia, 10330
Medan, Indonesia, 20152
Semarang, Indonesia, 50241
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78306
Beer Sheva, Israel, 84101
Haifa, Israel, 34362
Haifa, Israel, 31048
Haifa, Israel, 31096
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
Cremona, Italy, 26100
Milano, Italy, 20132
Milano, Italy, 20122
Milano, Italy, 20142
Napoli, Italy, 80131
Padova, Italy, 35128
Palermo, Italy, 90127
Parma, Italy, 43100
Pavia, Italy, 27100
Piacenza, Italy, 29100
Reggio Emilia, Italy, 42100
Varese, Italy, 21100
Venezia, Italy, 30122
Korea, Republic of
Seoul, Korea, Korea, Republic of, 110-744
Daegu, Korea, Republic of, 705-718
Daegu, Korea, Republic of, 700721
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 137-701
Taegu, Korea, Republic of, 700-712
Malaysia
Selangor, Malaysia, 68000
Netherlands
Amsterdam, Netherlands, 1105 AZ
Arnhem, Netherlands, 6815 AD
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, 2024
Auckland, New Zealand, 0622
Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Palmerston North, New Zealand, 4414
Wellington South, New Zealand, 6021
Norway
Fredrikstad, Norway, 1603
Oslo, Norway, 0407
Rud, Norway, 1309
Trondheim, Norway, 7006
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, 60-631
Poznan, Poland, 61-848
Torun, Poland, 87-100
Warszawa, Poland, 02-097
Warszawa, Poland, 01-138
Warszawa, Poland, 04-479
Wroclaw, Poland, 50-326
Wroclaw, Poland, 51-124
Puerto Rico
San Juan, Puerto Rico, 00927
Singapore
Singapore, Singapore, 308433
Singapore, Singapore, 169608
South Africa
Cape Town, Cape, South Africa, 7500
Johannesburg, Gauteng, South Africa, 2132
Johannesburg, Gauteng, South Africa, 2193
Johannesburg, Gauteng, South Africa, 2191
Johannesburg, Gauteng, South Africa, 1724
Johannesburg, Gauteng, South Africa, 2157
Pretoria, Gauteng, South Africa, 0084
Pretoria, Gauteng, South Africa, 0181
Pretoria, Gauteng, South Africa, 0157
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
Genéve 14, Genève 14, Switzerland, 1211
Chur, Graubünden, Switzerland, 7000
Lausanne, Waadt, Switzerland, 1011
Lausanne, Waadt, Switzerland, 1005
Luzern, Switzerland, 6000
Zürich, Switzerland, 8091
Taiwan
Kaosiung, Kaoshiong, Taiwan, 807
Taichung, Taiwan, 40705
Taipei, Taiwan, 10016
Taipei, Taiwan, 220
Taipei, Taiwan, 112
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
Isleworth, Greater London, United Kingdom, TW7 6AF
London, Greater London, United Kingdom, SE1 7EH
London, Greater London, United Kingdom, SE5 9RS
London, United Kingdom
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: NCT00440193     History of Changes
Other Study ID Numbers: 11702a, 2006-004495-13, 11702b
Study First Received: February 23, 2007
Results First Received: November 22, 2012
Last Updated: January 26, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Canada: Ethics Review Committee
Canada: Health Canada
China: Ethics Committee
China: Food and Drug Administration
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
European Union: European Medicines Agency
Finland: Ethics Committee
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
India: Institutional Review Board
Indonesia: National Agency of Drug and Food Control
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
Malaysia: The National Pharmaceutical Control Bureau (NPCB)
Netherlands: Independent Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Health and Disability Ethics Committees
New Zealand: Medsafe
Norway: Ethics Committee
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Philippines: Ethics Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Switzerland: Swissmedic
Taiwan: Center for Drug Evaluation
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Thailand: National Research Council of Thailand (NCRT):
Thailand: Medical Council of Thailand (MCT)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014