Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (MAGELLAN)

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00571649
First received: December 11, 2007
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

  • Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.


Secondary Outcome Measures:
  • Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).

  • Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

  • Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).

  • Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90 [ Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days ] [ Designated as safety issue: No ]
    Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90

  • Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.

  • Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events

  • Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90 [ Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days ] [ Designated as safety issue: No ]
    Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.

  • Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

  • Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

  • Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days [ Time Frame: Up to Day 90 + 7 days ] [ Designated as safety issue: No ]
    All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.

  • Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days) [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: Yes ]
    Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding

  • Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days) [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: Yes ]
    Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.


Enrollment: 8101
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
Drug: Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Active Comparator: Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
Drug: Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
Drug: Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Detailed Description:

The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged 40 years or more
  • Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

    • Heart failure, New York Heart Association (NYHA) class III or IV
    • Active cancer
    • Acute ischemic stroke
    • Acute infectious and inflammatory diseases, including acute rheumatic diseases
    • Acute respiratory insufficiency
    • Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

  • Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
  • Conditions that may increase the risk of bleeding, including intracranial hemorrhage
  • Required drugs or procedures which may interfere with the study treatment
  • Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
  • General conditions in which subjects are not suitable to participate in the study
  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: NCT00571649

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
Birmingham, Alabama, United States, 35235
Dothan, Alabama, United States, 36301
Geneva, Alabama, United States, 36340
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36111
Tuscaloosa, Alabama, United States, 35401
Tuscaloosa, Alabama, United States, 35406
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Chula Vista, California, United States, 91911
Duarte, California, United States, 91010
Encinitas, California, United States, 92024
Fountain Valley, California, United States, 92708
Fullerton, California, United States, 92835
Glendale, California, United States, 91206
Oceanside, California, United States, 92056
Pasadena, California, United States, 91105
Redlands, California, United States, 92373
Sacramento, California, United States, 95817
San Diego, California, United States, 92120
Santa Barbara, California, United States, 93102
Torrance, California, United States, 90502-2004
United States, Colorado
Denver, Colorado, United States, 80204
Pueblo, Colorado, United States, 81003
Wheat Ridge, Colorado, United States, 80033-6017
United States, Connecticut
Farmington, Connecticut, United States, 06030
United States, Delaware
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Aventura, Florida, United States, 33180
Boyton Beach, Florida, United States, 33472
Clearwater, Florida, United States, 33756
Delray Beach, Florida, United States, 33445
Ft. Lauderdale, Florida, United States, 33334
Hollywood, Florida, United States, 33021
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33173-3259
Miami, Florida, United States, 33136
Miami Springs, Florida, United States, 33166
Pembroke Pines, Florida, United States, 33024
Port Charlotte, Florida, United States, 33952
Sarasota, Florida, United States, 34232
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30342
Decatur, Georgia, United States, 30030
Fort Gordon, Georgia, United States, 30905
Savannah, Georgia, United States, 31405
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60611
Springfield, Illinois, United States, 62702
United States, Indiana
Anderson, Indiana, United States, 46011
Noblesville, Indiana, United States, 46060
United States, Iowa
Des Moines, Iowa, United States, 50314-2611
United States, Kansas
Olathe, Kansas, United States, 66061
United States, Louisiana
Lafayette, Louisiana, United States, 70503
New Orleans, Louisiana, United States, 70121
Shreveport, Louisiana, United States, 71130-4228
United States, Maine
Biddeford, Maine, United States, 04005
Rockport, Maine, United States, 04856
United States, Maryland
Baltimore, Maryland, United States, 21237
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Framingham, Massachusetts, United States, 01702
United States, Michigan
Ann Arbor, Michigan, United States, 48106
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
Grand Rapids, Michigan, United States, 49525
Lansing, Michigan, United States, 48910
Petoskey, Michigan, United States, 49770-2297
Pontiac, Michigan, United States, 48341
St. Clair Shores, Michigan, United States, 48081
United States, Minnesota
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Kansas City, Missouri, United States, 64128
St. Louis, Missouri, United States, 63110
St. Louis, Missouri, United States, 63141
United States, Montana
Anaconda, Montana, United States, 59711-2718
Great Falls, Montana, United States, 59405
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Hackensack, New Jersey, United States, 07601-1991
New Brunswick, New Jersey, United States, 08901
Somerville, New Jersey, United States, 08876-2598
Summit, New Jersey, United States, 07901
Teaneck, New Jersey, United States, 07666
United States, New York
Brooklyn, New York, United States, 11215
Buffalo, New York, United States, 14215-3021
Jamaica, New York, United States, 11418
New Hyde Park, New York, United States, 11040-1496
New York, New York, United States, 10011
New York, New York, United States, 10065
Stony Brook, New York, United States, 11794
Valhalla, New York, United States, 10595
United States, North Carolina
Durham, North Carolina, United States, 27710
Elizabeth City, North Carolina, United States, 27909
Greensboro, North Carolina, United States, 27403
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Canton, Ohio, United States, 44718
Columbus, Ohio, United States, 43215
Maumee, Ohio, United States, 43537-1899
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Camp Hill, Pennsylvania, United States, 17011
Danville, Pennsylvania, United States, 17822
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19124
Scranton, Pennsylvania, United States, 18510
Wilkes-Barre, Pennsylvania, United States, 18711-3752
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Memphis, Tennessee, United States, 38104
Nashville, Tennessee, United States, 37232-2650
United States, Texas
Corsicana, Texas, United States, 75110
Dallas, Texas, United States, 75216-7167
Edinburg, Texas, United States, 78539
Houston, Texas, United States, 77024
Houston, Texas, United States, 77030-4009
Houston, Texas, United States, 77030
McAllen, Texas, United States, 78503
San Antonio, Texas, United States, 78218
United States, Utah
Ogden, Utah, United States, 84403
United States, Virginia
Richmond, Virginia, United States, 23249
Richmond, Virginia, United States, 23298
United States, Washington
Everett, Washington, United States, 98201
Tacoma, Washington, United States, 98405
United States, West Virginia
Clarksburg, West Virginia, United States, 26301
Argentina
Avellaneda, Buenos Aires, Argentina, B1870CID
San Miguel, Buenos Aires, Argentina, 1663
Tres de Febrero, Buenos Aires, Argentina, 1657
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1221
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1280
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1431FWO
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1039AAO
Vicente López, Argentina, 1638
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Kogarah, New South Wales, Australia, 2217
Lismore, New South Wales, Australia, 2480
Sydney, New South Wales, Australia, 2229
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Brisbane, Queensland, Australia, 4101
Brisbane, Queensland, Australia, 4066
Redcliffe, Queensland, Australia, 4020
Southport, Queensland, Australia, 4215
Woollongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5042
Australia, Tasmania
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Clayton, Victoria, Australia, 3168
Melbourne, Victoria, Australia, 3135
Melbourne, Victoria, Australia, 3144
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Austria
Kittsee, Burgenland, Austria, 2421
Oberpullendorf, Burgenland, Austria, 7350
Wolfsberg, Kärnten, Austria, 9400
Linz, Oberösterreich, Austria, 4020
Gratwein, Steiermark, Austria, 8113
Graz, Steiermark, Austria, 8036
Hartberg, Steiermark, Austria, 8230
Leoben, Steiermark, Austria, 8700
Zams, Tirol, Austria, 6511
Innsbruck, Austria, 6020
Linz, Austria, 4020
Mürzzuschlag, Austria, 8680
St. Pölten, Austria, 3100
Wien, Austria, 1100
Wien, Austria, 1030
Wien, Austria, 1140
Belgium
Aalst, Belgium, 9300
Brugge, Belgium, 8000
Bruxelles - Brussel, Belgium, 1000
Dendermonde, Belgium, 9200
Hasselt, Belgium, 3500
HUY, Belgium, 4500
Ieper, Belgium, 8900
Leuven, Belgium, 3000
Malmedy, Belgium, 4960
MOL, Belgium, 2400
Montigny S/sambre, Belgium, 6061
Mortsel, Belgium, 2640
Roeselare, Belgium, 8800
Sint-niklaas, Belgium, 9100
Tubize, Belgium, 1480
Turnhout, Belgium, 2300
Brazil
Curitiba, Parana, Brazil, 80050-350
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Campinas, Sao Paulo, Brazil, 130839 970
Santo Andre, Sao Paulo, Brazil, 09190-610
São Paulo, Sao Paulo, Brazil, 04039 002
São Paulo, Sao Paulo, Brazil, 01323-001
Sao Paulo, Brazil, 05403-900
Sao Paulo, Brazil, 05443000
Bulgaria
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2B7
Edmonton, Alberta, Canada, T6L 5X8
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Cobourg, Ontario, Canada, K9A 5W6
Ottawa, Ontario, Canada, K1Y 4E9
Scarborough, Ontario, Canada, M1P 2V5
Toronto, Ontario, Canada, M5T 2S8
Windsor, Ontario, Canada, N9A 1E1
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3T 1M5
Montreal, Quebec, Canada, H2L 4M1
Ste-Foy, Quebec, Canada, G1V 4G5
Canada
Quebec, Canada, G1J 1Z4
Quebec, Canada, G1V 4G5
Chile
Santiago, Chile
Santiago, Chile, 760 0448
Viña del Mar, Chile
China, Guangdong
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China, 510120
Guangzhou, Guangdong, China, 510405
China, Hunan
Changsha, Hunan, China, 410013
China, Jiangsu
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China, 210008
China, Jilin
Changchun, Jilin, China
China, Liaoning
Dalian, Liaoning, China, 116027
Shenyang, Liaoning, China, 110004
Shenyang, Liaoning, China, 110015
Shenyang, Liaoning, China, 110001
China, Shaanxi
Xi'an, Shaanxi, China, 710061
Xi'an, Shaanxi, China, 710032
China, Sichuan
Chengdu, Sichuan, China, 610041
China
Beijing, China, 100037
Beijing, China, 100005
Beijing, China, 100853
Beijing, China, 100044
Beijing, China, 100034
Beijing, China, 100020
Beijing, China, 100050
Beijing, China, 100088
Beijing, China, 100029
Beijing, China, 100053
Chongqing, China, 400042
Chongqing, China, 400038
Shanghai, China
Shanghai, China, 200003
Shanghai, China, 200025
Shanghai, China, 200233
Shanghai, China, 200127
Colombia
Medellín, Antioquia, Colombia
Bogotá, Distrito Capital de Bogotá, Colombia
Cali, Valle del Cauca, Colombia
Bogota, Colombia
Bogotá, Colombia
Cali, Colombia
Medellín, Colombia
Croatia
Osijek, Croatia, 310 00
Rijeka, Croatia, 51000
Zadar, Croatia, 23000
Zagreb, Croatia, 1000
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 91
Kutna Hora, Czech Republic, 284 30
Nove Mesto na Morave, Czech Republic, 592 31
Olomouc, Czech Republic, 775 20
Plzen, Czech Republic, 305 99
Praha 2, Czech Republic, 12800
Praha 2, Czech Republic, 128 21
Praha 2, Czech Republic, 128 08
Ricany, Czech Republic, 251 49
Znojmo, Czech Republic, 669 02
Denmark
Esbjerg, Denmark, 6700
Frederiksberg C, Denmark, 2000
Kolding, Denmark, 6000
København NV, Denmark, 2400
København S, Denmark, 2300
Roskilde, Denmark, 4000
Estonia
Tallinn, Estonia, 13419
Tallinn, Estonia, EE-10617
Tallinn, Estonia, 10138
Tartu, Estonia, EE-51014
Finland
Helsinki, Finland, 00290
Hämeenlinna, Finland, 13530
Jyväskylä, Finland, 40620
Lahti, Finland, 15850
Lappeenranta, Finland, 53100
Raisio, Finland, 21200
Turku, Finland, 20700
Turku, Finland, 20520
France
Arras, France, 62000
Besancon, France, 25000
Brest Cedex, France, 29609
Castelnau Le Lez, France, 34170
Clermont Ferrand, France, 63000
Colombes Cedex, France, 92701
Dijon, France, 21000
Lille, France, 59307
Lille, France, 59037
Limoges, France, 87042
Lomme, France, 59160
Lyon, France, 69003
Montpellier Cedex, France, 34295
Nice, France, 06280
Nimes, France, 30029
Paris, France, 75010
Paris, France, 75877
Paris, France, 75004
Paris, France, 75475
Pierre Benite, France, 69495
Reims, France, 51092
Roubaix, France, 59100
Saint Herblain Cedex, France, 44805
Saint-etienne, France, 42000
Strasbourg Cedex, France, 67091
Toulouse, France, 31403
TOURCOING cedex, France, 59208
Vandoeuvre Les Nancy, France, 54511
Germany
Bad Mergentheim, Baden-Württemberg, Germany, 97980
Esslingen, Baden-Württemberg, Germany, 73730
Heidelberg, Baden-Württemberg, Germany, 69120
Karlsbad, Baden-Württemberg, Germany, 76307
Weiden, Bayern, Germany, 92637
Beeskow, Brandenburg, Germany, 15848
Frankfurt/Oder, Brandenburg, Germany, 15236
Dortmund, Nordrhein-Westfalen, Germany, 44137
Jülich, Nordrhein-Westfalen, Germany, 52428
Köln, Nordrhein-Westfalen, Germany, 51067
Köln, Nordrhein-Westfalen, Germany, 50935
Köln, Nordrhein-Westfalen, Germany, 51109
Leverkusen, Nordrhein-Westfalen, Germany, 51375
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Neuss, Nordrhein-Westfalen, Germany, 41464
Oberhausen, Nordrhein-Westfalen, Germany, 46045
Paderborn, Nordrhein-Westfalen, Germany, 33098
Soest, Nordrhein-Westfalen, Germany, 59494
Stolberg, Nordrhein-Westfalen, Germany, 52222
Troisdorf, Nordrhein-Westfalen, Germany, 53844
Viersen, Nordrhein-Westfalen, Germany, 41749
Wuppertal, Nordrhein-Westfalen, Germany, 42109
Mainz, Rheinland-Pfalz, Germany, 55131
Neuwied, Rheinland-Pfalz, Germany, 56564
Halle, Sachsen-Anhalt, Germany, 06112
Dresden, Sachsen, Germany, 01307
Dresden, Sachsen, Germany, 01067
Leipzig, Sachsen, Germany, 04289
Pirna, Sachsen, Germany, 01796
Berlin, Germany, 10787
Bremen, Germany, 28177
Greece
Abelokipi - Athens, Attica, Greece, 115 22
Athens, Attica, Greece, 106 76
Elefsina, Attica, Greece, 19018
Kifisia / Athens, Attica, Greece, 14561
Rio, Patras, Greece, 265 04
Athens, Greece, 115 27
Athens, Greece, 156 69
Nea Ionia, Greece, 14233
Piraeus, Greece, 18536
Hong Kong
Shatin, N.t., Hong Kong
Shatin, New Territories, Hong Kong
Hungary
Baja, Hungary, 6500
Balassagyarmat, Hungary, 2660
Budapest, Hungary, 1076
Budapest, Hungary, 1134
Budapest, Hungary, 1145
Debrecen, Hungary, 4012
Gyor, Hungary, 9024
Hodmezovasarhely, Hungary, 6800
Kecskemet, Hungary, 6000
Szekesfehervar, Hungary, 8000
Tatabanya, Hungary, 2800
Zalaegerszeg-Pozva, Hungary, H-8900
India
Ahmedabad, Gujar?t, India, 380 054
Bangalore, Karn?taka, India, 560099
Bangalore, Karn?taka, India, 560052
Calicut, Kerala, India, 673 004
Thiruvananthapuram, Kerala, India, 695002
Pune, Maharashtra, India, 411011
Pune, Maharashtra, India, 411001
Ludhiana, Punjab, India, 141001
Chennai, Tamil N?du, India, 600081
Coimbatore, Tamil N?du, India, 641 004
Kolkata, West Bengal, India, 700 099
Hyderabad, India, 500082
Hyderabad, India, 500034
Hyderabad, India, 600 038
Mumbai, India, 400022
Noida, India
Indonesia
Jakarta, Indonesia, 10430
Jakarta, Indonesia, 11420
Surabaya, Indonesia, 60286
Israel
Afula, Israel, 1834111
Ashkelon, Israel, 7830604
Haifa, Israel, 3525408
Haifa, Israel, 31048
Haifa, Israel, 3109601
Holon, Israel, 58100
Kfar Saba, Israel, 4428164
Rehovot, Israel, 7610001
Safed, Israel, 1311001
Tel Aviv, Israel, 64239
Italy
Acquaviva delle Fonti, Bari, Italy, 70021
Rozzano, Milano, Italy, 20089
Fidenza, Parma, Italy, 43036
Gubbio, Perugia, Italy, 06024
Orvieto, Terni, Italy, 05019
Domodossola, Verbano-Cusio-Ossola, Italy, 28845
Bergamo, Italy, 24128
Campobasso, Italy, 86100
Catania, Italy, 95124
Genova, Italy, 16128
Latina, Italy, 04100
Milano, Italy, 20133
Milano, Italy, 20162
Modena, Italy, 41100
Napoli, Italy, 80123
Palermo, Italy, 90127
Parma, Italy, 43100
Perugia, Italy, 06156
Piacenza, Italy, 29100
Reggio Calabria, Italy, 89124
Reggio Emilia, Italy, 42100
Roma, Italy, 00161
Roma, Italy, 00168
Varese, Italy, 21100
Vicenza, Italy, 36100
Japan
Ichinomiya, Aichi, Japan, 491-8551
Kasugai, Aichi, Japan, 487-0013
Obu, Aichi, Japan, 474-8511
Matsuyama, Ehime, Japan, 790-0024
Toon, Ehime, Japan, 791-0281
Chikushino, Fukuoka, Japan, 818-8516
Takasaki, Gunma, Japan, 370-0829
Kure, Hiroshima, Japan, 737-0023
Hakodate, Hokkaido, Japan, 040-8611
Sapporo, Hokkaido, Japan, 065-0033
Amagasaki, Hyogo, Japan, 660-8511
Kanazawa, Ishikawa, Japan, 920-8650
Hanamaki, Iwate, Japan, 025-0075
Ebina, Kanagawa, Japan, 243-0433
Kamakura, Kanagawa, Japan, 247-8533
Yokohama, Kanagawa, Japan, 236-0051
Nangoku, Kochi, Japan, 783-8509
Matsusaka, Mie, Japan, 515-8544
Tsu, Mie, Japan, 514-8507
Tsu, Mie, Japan, 514-1101
Kashiwazaki, Niigata, Japan, 945-8585
Tomigusuku, Okinawa, Japan, 901-0243
Urasoe, Okinawa, Japan, 901-2132
Daito, Osaka, Japan, 574-0074
Yao, Osaka, Japan, 581-0011
Kusatsu, Shiga, Japan, 525-8585
Hamamatsu, Shizuoka, Japan, 432-8580
Meguro-ku, Tokyo, Japan, 152-8902
Shinjuku-ku, Tokyo, Japan, 162-8655
Shimonoseki, Yamaguchi, Japan, 750-0061
Fukui, Japan, 910-8561
Ibaraki, Japan, 319-1113
Kumamoto, Japan, 860-0008
Kyoto, Japan, 606-8507
Korea, Republic of
Gyeongi-do, Korea, Korea, Republic of, 463-707
Jeollanam-do, Korea, Korea, Republic of, 519-763
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 156-707
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Gyeonggi-do, Korea, Republic of, 463-712
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138736
Latvia
Daugavpils, Latvia, LV-5417
Liepaja, Latvia, 3402
Riga, Latvia, 1005
Riga, Latvia, LV-1038
Riga, Latvia, 1002
Riga, Latvia
Valmiera, Latvia, LV-4201
Ventspils, Latvia, LV-3601
Lithuania
Kaunas, Lithuania, LT-3026
Kaunas, Lithuania, LT-3002
Kaunas, Lithuania, LT-3000
Klaipeda, Lithuania, LT-5800
Klaipeda, Lithuania, LT-92231
Siauliai, Lithuania, 76231
Utena, Lithuania, LT-28142
Vilnius, Lithuania, 04130
Vilnius, Lithuania, 10207
Vilnius, Lithuania, LT-2001
Luxembourg
Kirchberg, Luxembourg, 2540
Luxembourg, Luxembourg, 1210
Niederkorn, Luxembourg, 4602
Malaysia
Kuala Lumpur, Malaysia, 59100
Negeri Sembilan,, Malaysia, 70300
Sarawak, Malaysia, 93400
Mexico
Tuxtla Gutiérrez, Chiapas, Mexico, 29000
Torreón, Coahuila, Mexico, 27250
Guadalajara, Jalisco, Mexico, 44280
Morelia, Michoacán, Mexico, 58270
Metepec, México, Mexico, 52140
Monterrey, Nuevo Leon, Mexico, 66480
Hermosillo, Sonora, Mexico, 83000
Mérida, Yucatán, Mexico, 97001
Aguascalientes, Mexico, 20234
Chihuahua, Mexico, 31350
Mexico D. F., Mexico, 06760
Mexico D.F., Mexico, 15900
Mexico D.F., Mexico, 11340
México, D.F, Mexico, 07460
México, D.F., Mexico, 06720
México, D.F., Mexico, 07760
Puebla, Mexico, 72410
Zacatecas, Mexico, 98000
Netherlands
Amersfoort, Netherlands, 3816 CP
Amsterdam, Netherlands, 1061 AE
Enschede, Netherlands, 7511 JX
Heerlen, Netherlands, 6401 CX
Maastricht, Netherlands, 6229 HX
Nieuwegein, Netherlands, 3435 CM
Rotterdam, Netherlands, 3083 AN
Sittard, Netherlands, 6131 BK
Utrecht, Netherlands, 3582 KE
New Zealand
Auckland, New Zealand, 0622
Auckland, New Zealand, 2024
Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Norway
Fredrikstad, Norway, 1603
Gjøvik, Norway, 2819
Hamar, Norway, 2326
Oslo, Norway, 0407
Oslo, Norway, 0319
Pakistan
Karachi, Pakistan, 75500
Karachi, Pakistan, 74800
Lahore, Pakistan
Peru
Callao, Peru, CALLAO 2
Lima, Peru, LIMA 11
Lima, Peru, LIMA 1
Lima, Peru, 01
Lima, Peru, 31
Lima Cercado, Peru, LIMA 1
Poland
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-681
Krakow, Poland, 31-121
Krakow, Poland, 31-066
Lublin, Poland, 20-178
Olsztyn, Poland, 10-228
Piotrkow Trybunalski, Poland, 97-300
Siedlce, Poland, 08-110
Starogard Gdanski, Poland, 83-200
Szczecin, Poland, 70-965
Tarnów, Poland, 33-100
Warszawa, Poland, 04-749
Warszawa, Poland, 03-401
Warszawa, Poland, 04-141
Wloclawek, Poland, 87-800
Portugal
S. Martinho do Bispo, Coimbra, Portugal, 3041-856
Amadora, Portugal, 2720-276
Cascais, Portugal, 2750-349
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1150-199
Lisboa, Portugal, 1849- 017
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1349-019
Matosinhos, Portugal, 4454-509
Porto, Portugal, 4200-319
Porto, Portugal, 4099-001
Santarém, Portugal, 2005
Viana do Castelo, Portugal, 4901-585
Romania
Bucharest, Romania, 022328
Bucharest, Romania, 041915
Bucharest, Romania, 014461
Constanta, Romania, 900591
Suceava, Romania, 720237
Russian Federation
Moscow, Russian Federation, 119048
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 119881
Moscow, Russian Federation, 125367
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 103030
Moscow, Russian Federation, 117292
Moscow, Russian Federation, 115516
Nizhny Novgorod, Russian Federation, 603001
Nizhny Novgorod, Russian Federation, 603035
Yaroslavl, Russian Federation, 150030
Yaroslavl, Russian Federation, 150003
Singapore
Singapore, Singapore, 529889
Singapore, Singapore, 168752
Singapore, Singapore, 308433
Singapore, Singapore, 119074
Singapore, Singapore, 169608
Slovakia
Bratislava, Slovakia, 813 69
Bratislava, Slovakia, 826 06
Lucenec, Slovakia, 984 39
Martin, Slovakia, 036 59
Zilina, Slovakia, 012 07
Slovenia
Golnik, Slovenia, 4204
Ljubljana, Slovenia, 1000
Novo mesto, Slovenia, 8000
South Africa
Bloemfontein, Freestate, South Africa, 9301
Johannesburg, Gauteng, South Africa, 2196
Johannesburg, Gauteng, South Africa, 2132
Johannesburg, Gauteng, South Africa, 2057
Kempton Park, Gauteng, South Africa, 1610
Pretoria, Gauteng, South Africa, 0084
Pretoria, Gauteng, South Africa, 0181
Pretoria, Gauteng, South Africa, 0157
Roodepoort, Gauteng, South Africa, 1724
Goodwood, Western Cape, South Africa, 7460
Somerset West, Western Cape, South Africa, 7130
Stellenbosch, Western Cape, South Africa, 7505
Worcester, Western Cape, South Africa, 6850
Sandton, Gauteng, South Africa, 2196
Spain
Badalona, Barcelona, Spain, 08916
Sabadell, Barcelona, Spain, 08208
Cabra, Córdoba, Spain, 14940
Olot, Girona, Spain, 17800
Cartagena, Murcia, Spain, 30202
Vélez, Málaga, Spain, 29700
Vigo, Pontevedra, Spain, 36214
Barcelona, Spain, 08023
Barcelona, Spain, 08036
Cuenca, Spain, 16002
Córdoba, Spain, 14004
Girona, Spain, 17007
Zaragoza, Spain, 50009
Sweden
Borås, Sweden, 501 82
Hässleholm, Sweden, 281 25
Karlshamn, Sweden, 374 80
Kristianstad, Sweden, 29185
Lund, Sweden, 221 85
Malmö, Sweden, 205 02
Skövde, Sweden, 541 85
Stockholm, Sweden, 182 88
Stockholm, Sweden, 171 76
Sundsvall, Sweden, 851 86
Umeå, Sweden, 90185
Visby, Sweden, 62184
Switzerland
Bruderholz, Basel-Landschaft, Switzerland, 4101
Basel, Basel-Stadt, Switzerland, 4031
Liestal, Basel-Stadt, Switzerland, 4410
Langenthal, Bern, Switzerland, 4901
Baden, Switzerland, 5404
Bern, Switzerland, 3010
Genève, Switzerland, 1211
Luzern, Switzerland, 6000
Zürich, Switzerland, 8091
Taiwan
Kaohsiung, Taiwan, 833
Tainan, Taiwan, 710
Taipei, Taiwan, 10016
Taipei, Taiwan, 114
Taipei, Taiwan
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiangmai, Thailand, 50200
Turkey
Istanbul, Turkey, 34304
Istanbul, Turkey, 34098
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Ukraine
Donetsk, Ukraine, 83003
Donetsk, Ukraine, 83045
Ivano-Frankivsk, Ukraine, 76000
Kharkiv, Ukraine, 61037
Kharkiv, Ukraine, 61178
Kharkiv, Ukraine, 61070
Kiev, Ukraine, 03680
Kiev, Ukraine, 04112
Kiev, Ukraine, 02 091
Kyiv, Ukraine, 01105
Lviv, Ukraine, 790 34
Odessa, Ukraine, 65025
Odessa, Ukraine, 65009
Simferopol, Ukraine, 95 026
Simferopol, Ukraine, 95023
United Kingdom
Middlesborough, Cleveland, United Kingdom, TS4 3BW
Dumfries, Dumfries and Galloway, United Kingdom, DG1 4EP
Liverpool, Merseyside, United Kingdom, L9 7JU
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Glasgow, Stratchclyde, United Kingdom, G11 6NT
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Leeds, West Yorkshire, United Kingdom, LS9 7TF
London, United Kingdom, SE5 9RS
London, United Kingdom, W1T 4EU
London, United Kingdom, N18 1QX
Nottingham, United Kingdom, NG7 2UH
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: Bayer
ClinicalTrials.gov Identifier: NCT00571649     History of Changes
Other Study ID Numbers: 12839, 2007-004614-14
Study First Received: December 11, 2007
Results First Received: February 16, 2012
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Acute medical illnesses with increased risk for VTE.
Deep vein thrombosis (DVT)
Pulmonary embolism (PE),
Venous Thromboembolic disease (VTE),
Medical illness

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

ClinicalTrials.gov processed this record on September 18, 2014