Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
This study has been completed.
Sponsor:
Bayer
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00439777
First received: February 23, 2007
Last updated: January 30, 2013
Last verified: January 2013
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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 pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Embolism |
Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Enoxaparin overlapping with and 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 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 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 VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal 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), 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, 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 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: | 4833 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
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 received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
Drug: Enoxaparin overlapping with and 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 hr 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.
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 PE with or without symptomatic DVT
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439777
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| 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, Missouri | |
| Chesterfield, Missouri, United States, 63017 | |
| 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, 27401 | |
| Greensboro, North Carolina, United States, 27403 | |
| 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 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Murray, Utah, United States, 84107 | |
| 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 | |
| Andorra | |
| Escaldes - Engordany, Andorra | |
| 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, 2229 | |
| Sydney, New South Wales, Australia, 2031 | |
| 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, Tasmania | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Box Hill, Victoria, Australia, 3128 | |
| Clayton, Victoria, Australia, 3168 | |
| Geelong, Victoria, Australia, 3220 | |
| Melbourne, Victoria, Australia, 3181 | |
| Melbourne, Victoria, Australia, 3135 | |
| 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 | |
| Linz, Austria, 4010 | |
| Wien, Austria, 1140 | |
| Wien, Austria, 1090 | |
| Wien, Austria, 1171 | |
| Belgium | |
| Aalst, Belgium, 9300 | |
| 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 | |
| Yvoir, Belgium, 5530 | |
| Zottegem, Belgium, 9620 | |
| Brazil | |
| 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 | |
| São Paulo, Sao Paulo, Brazil, 01323-001 | |
| São Paulo, Sao Paulo, Brazil, 08270-070 | |
| Rio de Janeiro, Brazil | |
| Sao Paulo, Brazil, 01509-900 | |
| 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 | |
| Guangzhou, Guangdong, China, 510120 | |
| Guangzhou, Guangdong, China, 510080 | |
| China, Guangxi | |
| Nanning, Guangxi, China, 530021 | |
| 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, 100020 | |
| Beijing, China, 100038 | |
| Beijing, China, 100853 | |
| Beijing, China, 100044 | |
| Beijing, China, 100029 | |
| Beijing, China, 100730 | |
| Beijing, China, 100037 | |
| Shanghai, China, 200001 | |
| Shanghai, China, 200032 | |
| Shanghai, China, 200433 | |
| Czech Republic | |
| 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 | |
| Rakovnik, Czech Republic, 269 01 | |
| Usti nad Lebem, Czech Republic, 401 13 | |
| Denmark | |
| Aarhus C, Denmark, 8000 | |
| Braedstrup, Denmark, 8740 | |
| Frederiksberg, Denmark, 2000F | |
| Estonia | |
| Tallinn, Estonia, 10138 | |
| Finland | |
| Tampere, Finland, 33521 | |
| Turku, Finland, 20520 | |
| 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 | |
| Dijon, France, 21000 | |
| Grenoble, France, 38043 | |
| Limoges, France, 87042 | |
| Metz-tessy, France, 74370 | |
| Montpellier Cedex, France, 34295 | |
| Nantes, France, 44000 | |
| Nice, France, 06002 | |
| Orthez, France, 64300 | |
| Paris, France, 75004 | |
| Paris, France, 75877 | |
| Paris, France, 75475 | |
| Paris, France, 75015 | |
| 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 | |
| Valenciennes Cedex, France, 59322 | |
| Vandoeuvre Les Nancy, France, 54511 | |
| Vernon, France, 27200 | |
| Germany | |
| Bruchsal, Baden-Württemberg, Germany, 76646 | |
| Heidelberg, Baden-Württemberg, Germany, 69115 | |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
| Karlsbad, Baden-Württemberg, Germany, 76307 | |
| 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 | |
| Frankfurt, Hessen, Germany, 60590 | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17475 | |
| Rotenburg, Niedersachsen, Germany, 27342 | |
| Essen, Nordrhein-Westfalen, Germany, 45122 | |
| Paderborn, Nordrhein-Westfalen, Germany, 33098 | |
| Witten, Nordrhein-Westfalen, Germany, 58455 | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Halle, Sachsen-Anhalt, Germany, 06120 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Dresden, Sachsen, Germany, 01307 | |
| Nordhausen, Thüringen, Germany, 99734 | |
| Berlin, Germany, 12099 | |
| Bottrop, Germany, 46242 | |
| 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 | |
| Szekszard, Hungary, 7100 | |
| Szentes, Hungary, 6600 | |
| Szombathely, Hungary, 9700 | |
| Zalaegerszeg, Hungary, 8900 | |
| India | |
| Kochi, Kerala, India, 682026 | |
| Hyderabad, India, 500082 | |
| New Delhi, India, 110060 | |
| Pune, India, 411001 | |
| Indonesia | |
| Bandung, Indonesia, 40161 | |
| Jakarta, Indonesia, 10430 | |
| Jakarta, Indonesia, 10330 | |
| Medan, Indonesia, 20152 | |
| Semarang, Indonesia, 50241 | |
| Ireland | |
| Ballinasloe, Co. Galway, Ireland | |
| Israel | |
| Afula, Israel, 18101 | |
| Ashkelon, Israel, 78278 | |
| 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 | |
| Rozzano, Milano, Italy, 20089 | |
| Bologna, Italy, 40138 | |
| Chieti, Italy, 66013 | |
| Milano, Italy, 20122 | |
| Milano, Italy, 20142 | |
| Milano, Italy, 20132 | |
| 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 | |
| Seoul, Korea, Republic of, 120-752 | |
| Taegu, Korea, Republic of, 700-712 | |
| Latvia | |
| Liepaja, Latvia, LV 3414 | |
| Lithuania | |
| Kaunas, Lithuania, LT-50009 | |
| Vilnius, Lithuania, LT-08661 | |
| Malaysia | |
| Selangor, Malaysia, 68000 | |
| Netherlands | |
| Amsterdam, Netherlands, 1105 AZ | |
| Arnhem, Netherlands, 6815 AD | |
| Enschede, Netherlands, 7511 JX | |
| Groningen, Netherlands, 9713 GZ | |
| Hoofddorp, Netherlands, 2134 TM | |
| Maastricht, Netherlands, 6229 HX | |
| Zwolle, Netherlands, 8025 AB | |
| New Zealand | |
| Auckland, New Zealand, 0622 | |
| Auckland, New Zealand, 1023 | |
| Auckland, New Zealand, 2024 | |
| 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 | |
| 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, 01-138 | |
| Wroclaw, Poland, 50-326 | |
| Wroclaw, Poland, 51-124 | |
| Puerto Rico | |
| San Juan, Puerto Rico, 00927 | |
| Singapore | |
| Singapore, Singapore, 308433 | |
| Singapore, Singapore, 169608 | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 2191 | |
| Johannesburg, Gauteng, South Africa, 2132 | |
| Johannesburg, Gauteng, South Africa, 2157 | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Pretoria, Gauteng, South Africa, 0157 | |
| Pretoria, Gauteng, South Africa, 0181 | |
| 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 | |
| Valladolid, Castilla - León, Spain, 47010 | |
| Palma de Mallorca, Illes Baleares, Spain, 07010 | |
| Requena, Valencia, Spain, 46340 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08025 | |
| Girona, Spain, 17007 | |
| Madrid, Spain, 28034 | |
| Pamplona, Spain, 31008 | |
| Sweden | |
| Borås, Sweden, 501 82 | |
| Göteborg, Sweden, 416 85 | |
| Göteborg, Sweden, 413 45 | |
| Jönköping, Sweden, 551 85 | |
| Stockholm, Sweden, 118 83 | |
| Sundsvall, Sweden, 851 86 | |
| Switzerland | |
| Genéve 14, Genève 14, Switzerland, 1211 | |
| Chur, Graubünden, Switzerland, 7000 | |
| Lausanne, Vaud, Switzerland, 1011 | |
| Lausanne, Waadt, Switzerland, 1005 | |
| Bern, Switzerland, 3010 | |
| Luzern, Switzerland, 6000 | |
| Zürich, Switzerland, 8091 | |
| Taiwan | |
| Taichung, Taiwan, 40705 | |
| Taipei, Taiwan, 10016 | |
| Taipei, Taiwan, 112 | |
| Taipei, Taiwan, 220 | |
| Thailand | |
| Bangkok, Thailand, 10400 | |
| Chiang Mai, Thailand, 50200 | |
| Pathumwan, Bangkok, Thailand, 10330 | |
| United Kingdom | |
| Plymouth, Devon, United Kingdom, PL6 8DH | |
| Isleworth, London, United Kingdom, TW7 6AF | |
| London, United Kingdom | |
| London, United Kingdom, SE1 7EH | |
| 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00439777 History of Changes |
| Other Study ID Numbers: | 11702b, 2006-004495-13 |
| Study First Received: | February 23, 2007 |
| Results First Received: | November 22, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Andorra: Ministeri de Salut i Benestar 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 Estonia: The State Agency of Medicine 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 Ireland: Irish Medicines Board Ireland: Research Ethics Committee Israel: Ethics Commission Israel: Ministry of Health Italy: Ethics Committee Italy: National Institute of Health Latvia: Institutional Review Board Latvia: State Agency of Medicines Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry 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 Peru: Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Peru: Instituto Nacional de Salud Peru: Ministry of Health Philippines: Bureau of Food and Drugs Philippines: Ethics Committee Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Health Ethic Committee Portugal: National Pharmacy and Medicines Institute Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control 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:
|
Pulmonary Embolism Embolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thrombosis |
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 May 23, 2013