check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

12839

ClinicalTrials.gov Identifier:

NCT00571649

EudraCT Number:

2007-004614-14

EU CT Number:

Not Available
Venous Thromboembolic Event (VTE) prophylaxis in medically ill patients

Trial 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.

Key Participants Requirements

Sex

Both

Age

40 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
8101
Trial Dates
December 2007 - November 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Paderborn, 33098, Germany
Withdrawn
Beeskow, 15848, Germany
Completed
Halle, 06112, Germany
Completed
Weiden, 92637, Germany
Withdrawn
Pirna, 01796, Germany
Completed
Leverkusen, 51375, Germany
Completed
Köln, 51067, Germany
Completed
Oberhausen, 46045, Germany
Completed
Wuppertal, 42109, Germany
Completed
Mönchengladbach, 41063, Germany
Completed
Dresden, 01307, Germany
Completed
Heidelberg, 69120, Germany
Withdrawn
Soest, 59494, Germany
Completed
Esslingen, 73730, Germany
Completed
Bremen, 28177, Germany
Completed
Karlsbad, 76307, Germany
Completed
Köln, 50935, Germany
Withdrawn
Neuwied, 56564, Germany
Completed
Berlin, 10787, Germany
Completed
Neuss, 41464, Germany
Completed
Frankfurt/Oder, 15236, Germany
Completed
Troisdorf, 53844, Germany
Completed
Stolberg, 52222, Germany
Completed
Viersen, 41749, Germany
Completed
Bad Mergentheim, 97980, Germany
Completed
Dortmund, 44137, Germany
Completed
Köln, 51109, Germany
Completed
Dresden, 01067, Germany
Completed
Mainz, 55131, Germany
Completed
London, W1T 4EU, United Kingdom
Completed
London, SE5 9RS, United Kingdom
Completed
London, N18 1QX, United Kingdom
Withdrawn
Middlesborough, TS4 3BW, United Kingdom
Completed
Elizabeth City, 27909, United States
Completed
Birmingham, 35209, United States
Completed
Dallas, 75216-7167, United States
Withdrawn
Durham, 27710, United States
Withdrawn
Fort Gordon, 30905, United States
Completed
Little Rock, 72205, United States
Completed
Philadelphia, 19107, United States
Withdrawn
Chicago, 60611, United States
Completed
Miami, 33136, United States
Completed
Leipzig, 04289, Germany
Completed
Mainz, 55131, Germany
Withdrawn
Jülich, 52428, Germany
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Completed
Leeds, LS9 7TF, United Kingdom
Withdrawn
Sheffield, S10 2JF, United Kingdom
Withdrawn
Nottingham, NG7 2UH, United Kingdom
Completed
Dumfries, DG1 4EP, United Kingdom
Withdrawn
Glasgow, G11 6NT, United Kingdom
Completed
Liverpool, L9 7JU, United Kingdom
Withdrawn
Columbus, 43215, United States
Withdrawn
Des Moines, 50314-2611, United States
Withdrawn
New Hyde Park, 11040-1496, United States
Completed
Kansas City, 64128, United States
Completed
St. Louis, 63110, United States
Completed
Minneapolis, 55417, United States
Completed
Clearwater, 33756, United States
Completed
Mobile, 36608, United States
Withdrawn
Biddeford, 04005, United States
Completed
Greensboro, 27403, United States
Completed
Detroit, 48201, United States
Completed
Omaha, 68131, United States
Completed
Montgomery, 36111, United States
Completed
Birmingham, 35209, United States
Completed
Maumee, 43537-1899, United States
Completed
Dothan, 36301, United States
Completed
Redlands, 92373, United States
Completed
Corsicana, 75110, United States
Withdrawn
Port Charlotte, 33952, United States
Completed
Richmond, 23249, United States
Completed
Petoskey, 49770-2297, United States
Withdrawn
New Orleans, 70121, United States
Completed
Chula Vista, 91911, United States
Completed
Oceanside, 92056, United States
Completed
Detroit, 48202, United States
Completed
Camp Hill, 17011, United States
Completed
Sacramento, 95817, United States
Completed
Valhalla, 10595, United States
Completed
Springfield, 62702, United States
Completed
Baltimore, 21237, United States
Withdrawn
Danville, 17822, United States
Terminated
Office of Dr. John Simmons, MDGeneva, 36340, United States
Completed
Canton, 44718, United States
Completed
Anaconda, 59711-2718, United States
Completed
Tacoma, 98405, United States
Completed
Summit, 07901, United States
Completed
Fountain Valley, 92708, United States
Withdrawn
New York, 10011, United States
Completed
Baltimore, 21215, United States
Completed
Delray Beach, 33445, United States
Completed
New York, 10065, United States
Completed
Rockport, 04856, United States
Completed
Richmond, 23298, United States
Withdrawn
Aventura, 33180, United States
Withdrawn
Grand Rapids, 49525, United States
Withdrawn
Glendale, 91206, United States
Completed
Nashville, 37232-2650, United States
Completed
Decatur, 30030, United States
Completed
McAllen, 78503, United States
Withdrawn
Olathe, 66061, United States
Completed
Shreveport, 71130-4228, United States
Withdrawn
Bethlehem, 18015, United States
Completed
Wilkes-Barre, 18711-3752, United States
Withdrawn
Scranton, 18510, United States
Completed
Torrance, 90502-2004, United States
Completed
Great Falls, 59405, United States
Completed
Ogden, 84403, United States
Completed
Somerville, 08876-2598, United States
Completed
Savannah, 31405, United States
Completed
New Brunswick, 08901, United States
Completed
Fargo, 58122, United States
Completed
Houston, 77024, United States
Completed
Lafayette, 70503, United States
Completed
Everett, 98201, United States
Withdrawn
Houston, 77030-4009, United States
Completed
Vero Beach, 32960, United States
Withdrawn
Stony Brook, 11794, United States
Withdrawn
Lansing, 48910, United States
Completed
Birmingham, 35235, United States
Completed
Anderson, 46011, United States
Withdrawn
Hackensack, 07601-1991, United States
Withdrawn
Idaho Falls, 83404, United States
Withdrawn
Farmington, 06030, United States
Withdrawn
Buffalo, 14215-3021, United States
Completed
San Diego, 92120, United States
Completed
Sarasota, 34232, United States
Withdrawn
Pasadena, 91105, United States
Withdrawn
Denver, 80204, United States
Withdrawn
Pontiac, 48341, United States
Withdrawn
Hollywood, 33021, United States
Completed
Teaneck, 07666, United States
Withdrawn
Pembroke Pines, 33024, United States
Withdrawn
Memphis, 38104, United States
Completed
New York, 10065, United States
Completed
St. Louis, 63141, United States
Withdrawn
Miami, 33173-3259, United States
Completed
Washington, 20037, United States
Withdrawn
Tuscaloosa, 35401, United States
Completed
SAINT-ETIENNE, 42000, France
Completed
BREST CEDEX, 29609, France
Completed
CLERMONT FERRAND, 63000, France
Withdrawn
BESANCON, 25000, France
Completed
PARIS, 75004, France
Withdrawn
REIMS, 51092, France
Completed
LOMME, 59160, France
Completed
Lyon, 69003, France
Completed
Lille, 59037, France
Completed
STRASBOURG CEDEX, 67091, France
Completed
DIJON, 21000, France
Completed
LIMOGES, 87042, France
Completed
Wheat Ridge, 80033-6017, United States
Completed
Tuscaloosa, 35406, United States
Withdrawn
Fullerton, 92835, United States
Withdrawn
Encinitas, 92024, United States
Completed
San Antonio, 78218, United States
Completed
Charleston, 29425, United States
Withdrawn
Atlanta, 30342, United States
Completed
Brooklyn, 11215, United States
Completed
Santa Barbara, 93102, United States
Completed
Ann Arbor, 48106, United States
Completed
Toledo, 43606, United States
Completed
Jamaica, 11418, United States
Withdrawn
Clarksburg, 26301, United States
Completed
Newark, 19718, United States
Completed
Edinburg, 78539, United States
Completed
Nimes, 30029, France
Completed
PARIS, 75010, France
Completed
NICE, 06280, France
Completed
Lille, 59307, France
Withdrawn
roubaix, 59100, France
Withdrawn
Saint Herblain Cedex, 44805, France
Withdrawn
Paris, 75877, France
Completed
TOULOUSE, 31403, France
Completed
Bydgoszcz, 85-681, Poland
Completed
Lublin, 20-178, Poland
Completed
Warszawa, 03-401, Poland
Completed
Szczecin, 70-965, Poland
Completed
Olsztyn, 10-228, Poland
Completed
Warszawa, 04-141, Poland
Completed
Bydgoszcz, 85-681, Poland
Completed
Sapporo, 065-0033, Japan
Withdrawn
Boyton Beach, 33472, United States
Withdrawn
Ft. Lauderdale, 33334, United States
Completed
MONTPELLIER CEDEX, 34295, France
Completed
PIERRE BENITE, 69495, France
Completed
COLOMBES CEDEX, 92701, France
Completed
PARIS, 75475, France
Withdrawn
VANDOEUVRE LES NANCY, 54511, France
Completed
CASTELNAU LE LEZ, 34170, France
Completed
TOURCOING cedex, 59208, France
Completed
ARRAS, 62000, France
Completed
Krakow, 31-066, Poland
Completed
Warszawa, 04-749, Poland
Completed
Krakow, 31-121, Poland
Completed
Bialystok, 15-276, Poland
Completed
Starogard Gdanski, 83-200, Poland
Completed
Yokohama, 236-0051, Japan
Completed
Kamakura, 247-8533, Japan
Completed
Kusatsu, 525-8585, Japan
Completed
Yao, 581-0011, Japan
Completed
Toon, 791-0281, Japan
Completed
Tomigusuku, 901-0243, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Withdrawn
Ichinomiya, 491-8551, Japan
Completed
Ichinomiya, 491-8551, Japan
Completed
National Hospital Organization Ibaraki Higashi HospitalIbaraki, 319-1113, Japan
Completed
Kyoto, 606-8507, Japan
Withdrawn
Hamamatsu, 432-8580, Japan
Withdrawn
Hakodate, 040-8611, Japan
Completed
Perugia, 06156, Italy
Completed
Genova, 16128, Italy
Withdrawn
Siedlce, 08-110, Poland
Completed
Piotrkow Trybunalski, 97-300, Poland
Completed
Tarnów, 33-100, Poland
Completed
Wloclawek, 87-800, Poland
Completed
Hanamaki, 025-0075, Japan
Completed
Takasaki, 370-0829, Japan
Completed
Meguro-ku, 152-8902, Japan
Completed
Ebina, 243-0433, Japan
Completed
Kashiwazaki, 945-8585, Japan
Completed
Kanazawa, 920-8650, Japan
Completed
Fukui, 910-8561, Japan
Completed
Tsu, 514-8507, Japan
Completed
Matsusaka, 515-8544, Japan
Withdrawn
Kure, 737-0023, Japan
Completed
Matsuyama, 790-0024, Japan
Completed
Chikushino, 818-8516, Japan
Completed
Palermo, 90127, Italy
Completed
Vicenza, 36100, Italy
Withdrawn
Reggio Calabria, 89124, Italy
Withdrawn
Bari, 70021, Italy
Completed
Napoli, 80123, Italy
Withdrawn
Campobasso, 86100, Italy
Completed
Roma, 00168, Italy
Completed
Domodossola, 28845, Italy
Completed
Perugia, 06024, Italy
Completed
Roma, 00161, Italy
Completed
Parma, 43126, Italy
Withdrawn
Córdoba, 14004, Spain
Withdrawn
Vigo, 36214, Spain
Completed
Zaragoza, 50009, Spain
Completed
Cabra, 14940, Spain
Withdrawn
Montreal, H3T 1M5, Canada
Completed
Kumamoto, 860-0008, Japan
Completed
Urasoe, 901-2132, Japan
Completed
Urasoe, 901-2132, Japan
Completed
Obu, 474-8511, Japan
Completed
Shimonoseki, 750-0061, Japan
Completed
Tsu, 514-1101, Japan
Completed
Nangoku, 783-8509, Japan
Completed
Amagasaki, 660-8511, Japan
Completed
Kasugai, 487-0013, Japan
Completed
Daito, 574-0074, Japan
Completed
Varese, 21100, Italy
Completed
Piacenza, 29121, Italy
Completed
Milano, 20089, Italy
Completed
Reggio Emilia, 42123, Italy
Completed
Milano, 20162, Italy
Completed
Latina, 04100, Italy
Completed
Edmonton, T5H 3V9, Canada
Completed
Quebec, G1J 1Z4, Canada
Withdrawn
Vancouver, V5Z 1M9, Canada
Completed
Scarborough, M1P 2V5, Canada
Withdrawn
Cobourg, K9A 5W6, Canada
Terminated
Hotel Dieu-Grace HospitalWindsor, N9A 1E1, Canada
Completed
Greenfield Park, J4V 2H1, Canada
Completed
Montreal, H2W 1T8, Canada
Withdrawn
Edmonton, T6G 2B7, Canada
Completed
AALST, 9300, Belgium
Withdrawn
SINT-NIKLAAS, 9100, Belgium
Withdrawn
IEPER, 8900, Belgium
Completed
TURNHOUT, 2300, Belgium
Withdrawn
MORTSEL, 2640, Belgium
Completed
HUY, 4500, Belgium
Withdrawn
HEERLEN, 6401 CX, Netherlands
Completed
Milano, 20133, Italy
Completed
Bergamo, 24128, Italy
Withdrawn
Catania, 95124, Italy
Completed
Fidenza, 43036, Italy
Completed
Modena, 41100, Italy
Completed
Terni, 05019, Italy
Completed
Badalona, 08916, Spain
Completed
Girona, 17007, Spain
Completed
Sabadell, 08208, Spain
Completed
Cuenca, 16002, Spain
Completed
Vélez, 29700, Spain
Completed
Olot, 17800, Spain
Completed
Barcelona, 08023, Spain
Completed
Cartagena, 30202, Spain
Completed
Barcelona, 08036, Spain
Completed
Edmonton, T6G 2B7, Canada
Withdrawn
ENSCHEDE, 7511 JX, Netherlands
Completed
AMSTERDAM, 1061 AE, Netherlands
Withdrawn
UTRECHT, 3582 KE, Netherlands
Completed
Chihuahua, 31350, Mexico
Completed
Hermosillo, 83000, Mexico
Completed
México, D.F., 07760, Mexico
Withdrawn
Mexico D. F., 06760, Mexico
Completed
Aguascalientes, 20234, Mexico
Withdrawn
Metepec, 52140, Mexico
Completed
Tuxtla Gutiérrez, 29000, Mexico
Completed
Puebla, 72410, Mexico
Completed
Morelia, 58270, Mexico
Completed
Mexico D.F., 15900, Mexico
Withdrawn
Mexico D.F., 11340, Mexico
Completed
Malmö, 205 02, Sweden
Completed
Quebec, G1V 4G5, Canada
Completed
Edmonton, T6L 5X8, Canada
Terminated
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Completed
Ottawa, K1Y 4E9, Canada
Withdrawn
Saint John, E2L 4L2, Canada
Withdrawn
Calgary, T2N 2T9, Canada
Completed
Toronto, M5T 2S8, Canada
Withdrawn
Ste-Foy, G1V 4G5, Canada
Completed
Montreal, H2L 4M1, Canada
Completed
LEUVEN, 3000, Belgium
Withdrawn
ROESELARE, 8800, Belgium
Completed
MOL, 2400, Belgium
Completed
HASSELT, 3500, Belgium
Withdrawn
BRUXELLES - BRUSSEL, 1000, Belgium
Withdrawn
MONTIGNY S/SAMBRE, 6061, Belgium
Completed
MALMEDY, 4960, Belgium
Completed
TUBIZE, 1480, Belgium
Completed
Hässleholm, 281 25, Sweden
Completed
Skövde, 541 85, Sweden
Completed
København NV, 2400, Denmark
Completed
Frederiksberg C, 2000, Denmark
Completed
Roskilde, 4000, Denmark
Completed
Hamar, 2326, Norway
Completed
Gjøvik, 2819, Norway
Completed
Sandton, Gauteng, 2196, South Africa
Completed
Johannesburg, 2196, South Africa
Completed
Kempton Park, 1610, South Africa
Withdrawn
Johannesburg, 2132, South Africa
Completed
Pretoria, 0084, South Africa
Completed
Worcester, 6850, South Africa
Completed
Praha 2, 12808, Czech Republic
Completed
Plzen, 305 99, Czech Republic
Completed
Olomouc, 775 20, Czech Republic
Completed
DENDERMONDE, 9200, Belgium
Completed
BRUGGE, 8000, Belgium
Withdrawn
NIEUWEGEIN, 3435 CM, Netherlands
Completed
Amersfoort, 3816 CP, Netherlands
Completed
MAASTRICHT, 6229 HX, Netherlands
Completed
ROTTERDAM, 3083 AN, Netherlands
Withdrawn
SITTARD, 6131 BK, Netherlands
Completed
Monterrey, 66480, Mexico
Completed
Guadalajara, 44280, Mexico
Completed
Torreón, 27250, Mexico
Withdrawn
Mérida, 97001, Mexico
Withdrawn
Ciudad de México, 06729, Mexico
Withdrawn
Zacatecas, 98000, Mexico
Completed
México, D.F, 07460, Mexico
Completed
Kristianstad, 29185, Sweden
Withdrawn
Holon, 58100, Israel
Completed
Kfar Saba, 4428164, Israel
Completed
Rehovot, 7661041, Israel
Completed
Zefat, 1311001, Israel
Completed
Afula, 1834111, Israel
Completed
Haifa, 3109601, Israel
Completed
Haifa, 3109601, Israel
Completed
Box Hill, 3128, Australia
Completed
Melbourne, 3135, Australia
Withdrawn
Southport, 4215, Australia
Withdrawn
Woollongabba, 4102, Australia
Completed
Kogarah, 2217, Australia
Completed
Sydney, 2229, Australia
Withdrawn
Adelaide, 5042, Australia
Completed
Redcliffe, 4020, Australia
Completed
Lismore, 2480, Australia
Completed
Sundsvall, 851 86, Sweden
Completed
Stockholm, 171 76, Sweden
Withdrawn
Visby, 62184, Sweden
Completed
Stockholm, 182 88, Sweden
Completed
Umeå, 90185, Sweden
Completed
Lund, 221 85, Sweden
Withdrawn
Borås, 501 82, Sweden
Withdrawn
Karlshamn, 374 80, Sweden
Completed
København S, 2300, Denmark
Withdrawn
Kolding, 6000, Denmark
Completed
Esbjerg, 6700, Denmark
Withdrawn
Oslo, 0407, Norway
Completed
Oslo, 0319, Norway
Completed
Fredrikstad, 1603, Norway
Completed
Pretoria, 0007, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Stellenbosch, 7505, South Africa
Completed
Clayton, 3168, Australia
Completed
Brisbane, 4101, Australia
Withdrawn
Brisbane, 4066, Australia
Completed
Perth, 6000, Australia
Withdrawn
Launceston, 7250, Australia
Completed
Sofia, 1233, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Ruse, 7002, Bulgaria
Completed
Varna, 9010, Bulgaria
Completed
Veliko Tarnovo, 5000, Bulgaria
Completed
Pleven, 5800, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Coimbra, 3000-075, Portugal
Completed
Porto, 4099-001, Portugal
Completed
Viana do Castelo, 4901-585, Portugal
Withdrawn
Amadora, 2720-276, Portugal
Completed
Johannesburg, 2057, South Africa
Completed
Pretoria, 0181, South Africa
Completed
Pretoria, 0084, South Africa
Completed
Pretoria, 0157, South Africa
Completed
Roodepoort, 1724, South Africa
Completed
Goodwood, 7460, South Africa
Completed
Bloemfontein, 9301, South Africa
Withdrawn
Brno, 656 91, Czech Republic
Completed
Praha 2, 128 08, Czech Republic
Withdrawn
Ricany, 251 49, Czech Republic
Completed
Praha 2, 128 21, Czech Republic
Completed
Nove Mesto na Morave, 592 31, Czech Republic
Completed
Znojmo, 669 02, Czech Republic
Withdrawn
Kutna Hora, 284 30, Czech Republic
Completed
Tel Aviv, 64239, Israel
Completed
Coimbra, 3000-075, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
Matosinhos, 4454-509, Portugal
Withdrawn
S. Martinho do Bispo, 3041-856, Portugal
Withdrawn
Cascais, 2750-349, Portugal
Completed
Hospital BritánicoBuenos Aires, 1280, Argentina
Terminated
Hospital de Agudos "Dr. Carlos Bocalandro"Tres de Febrero, 1657, Argentina
Completed
Buenos Aires, C1431FWO, Argentina
Completed
Avellaneda, B1870CID, Argentina
Completed
Graz, 8036, Austria
Completed
Hartberg, 8230, Austria
Withdrawn
Oberpullendorf, 7350, Austria
Completed
Wien, 1100, Austria
Completed
Wien, 1100, Austria
Completed
Ashkelon, 7830604, Israel
Completed
Holon, 58100, Israel
Completed
Haifa, 3339419, Israel
Withdrawn
Garran, 2605, Australia
Completed
Auchenflower, 4066, Australia
Completed
Melbourne, 3144, Australia
Completed
Stara Zagora, 6000, Bulgaria
Completed
Lisboa, 1849- 017, Portugal
Completed
Porto, 4200-319, Portugal
Withdrawn
Lisboa, 1150-199, Portugal
Completed
Lisboa, 1349-019, Portugal
Completed
Santarém, 2005, Portugal
Completed
Sanatorio MitreBuenos Aires, C1039AAO, Argentina
Completed
San Miguel, 1663, Argentina
Completed
Vicente López, 1638, Argentina
Completed
Zams, 6511, Austria
Completed
Gratwein, 8113, Austria
Completed
Leoben, 8700, Austria
Withdrawn
Mürzzuschlag, 8680, Austria
Completed
Wien, 1030, Austria
Completed
Viña del Mar, Chile
Completed
Kecskemet, 6000, Hungary
Completed
Budapest, 1134, Hungary
Completed
Tatabanya, 2800, Hungary
Completed
Balassagyarmat, 2660, Hungary
Withdrawn
Debrecen, 4012, Hungary
Withdrawn
Gyor, 9024, Hungary
Completed
Istanbul, 34304, Turkey
Completed
Istanbul, 34098, Turkey
Completed
Izmir, 35100, Turkey
Completed
Izmir, 35340, Turkey
Completed
Buenos Aires, 1221, Argentina
Completed
Linz, 4020, Austria
Completed
Innsbruck, 6020, Austria
Completed
Wolfsberg, 9400, Austria
Withdrawn
Linz, 4020, Austria
Completed
Linz, 4020, Austria
Completed
Kittsee, 2421, Austria
Withdrawn
Wien, 1140, Austria
Completed
St. Pölten, 3100, Austria
Completed
Santiago, Chile
Withdrawn
Santiago, Chile
Withdrawn
Santiago, 760 0448, Chile
Completed
Zalaegerszeg-Pozva, H-8900, Hungary
Completed
Baja, 6500, Hungary
Completed
Budapest, 1145, Hungary
Completed
Izmir, 35100, Turkey
Completed
Bogotá, Colombia
Completed
Medellín, Colombia
Completed
Bogota, Colombia
Completed
Bogotá, Colombia
Withdrawn
Bogotá, Colombia
Completed
Medellín, Colombia
Completed
Rio / Patras, 265 04, Greece
Completed
Athens, 156 69, Greece
Completed
Elefsina, 19018, Greece
Completed
Kifisia / Athens, 14561, Greece
Completed
Abelokipi - Athens, 115 26, Greece
Completed
Porto Alegre, 90610-000, Brazil
Completed
São Bernardo do Campo, 09715-090, Brazil
Completed
São Paulo, 04039 002, Brazil
Completed
Curitiba, 80050-350, Brazil
Withdrawn
Szekesfehervar, 8000, Hungary
Withdrawn
Hodmezovasarhely, 6800, Hungary
Completed
Budapest, 1145, Hungary
Withdrawn
Budapest, 1076, Hungary
Completed
Izmir, 35100, Turkey
Completed
Cali, Colombia
Completed
Medellín, Colombia
Completed
Cali, Colombia
Completed
Athens, 106 76, Greece
Completed
Athens, 156 69, Greece
Completed
Piraeus, 18536, Greece
Completed
Athens, 115 26, Greece
Completed
Nea Ionia, 14233, Greece
Completed
Sao Paulo, 05443000, Brazil
Completed
Sao Paulo, 05403-900, Brazil
Withdrawn
Moscow, 119048, Russia
Completed
Moscow, 115093, Russia
Withdrawn
Nizhny Novgorod, 603001, Russia
Completed
Kyiv, 01105, Ukraine
Completed
Simferopol, 95023, Ukraine
Completed
Kiev, 03680, Ukraine
Completed
Kharkiv, 61037, Ukraine
Completed
Ivano-Frankivsk, 76000, Ukraine
Completed
Kiev, 03680, Ukraine
Completed
Kharkiv, 61178, Ukraine
Completed
Kiev, 02 091, Ukraine
Completed
Ivano-Frankivsk, 76000, Ukraine
Completed
Odessa, 65009, Ukraine
Completed
Simferopol, 95 026, Ukraine
Completed
Lviv, 790 34, Ukraine
Completed
Odessa, 65025, Ukraine
Completed
Campinas, 130839 970, Brazil
Completed
São Paulo, 01323-001, Brazil
Completed
Moscow, 125367, Russia
Completed
Moscow, 125101, Russia
Completed
Moscow, 125101, Russia
Completed
Moscow, 103030, Russia
Withdrawn
Moscow, 119435, Russia
Completed
Moscow, 117292, Russia
Withdrawn
Moscow, 115516, Russia
Completed
Yaroslavl, 150030, Russia
Completed
Yaroslavl, 150003, Russia
Withdrawn
Nizhny Novgorod, 603035, Russia
Completed
Bratislava, 813 69, Slovakia
Completed
Bratislava, 826 06, Slovakia
Completed
Zilina, 012 07, Slovakia
Withdrawn
Kharkiv, 61070, Ukraine
Completed
Beijing, 100044, China
Completed
Shanghai, China
Completed
Shanghai, China
Completed
Shanghai, 200003, China
Completed
Beijing, 100088, China
Completed
Beijing, 100088, China
Completed
Beijing, 100053, China
Terminated
Beijing Friendship Hosp.Beijing, 100050, China
Completed
Nanjing, 210008, China
Completed
Nanjing, 210008, China
Completed
Nanjing, China
Withdrawn
Dalian, 116027, China
Completed
Guangzhou, China
Completed
Martin, 036 59, Slovakia
Completed
Lucenec, 984 39, Slovakia
Completed
Donetsk, 83003, Ukraine
Completed
Kyiv, 04112, Ukraine
Completed
Donetsk, 83045, Ukraine
Completed
Beijing, 100020, China
Completed
Beijing, 100050, China
Completed
Beijing, 100037, China
Completed
Shanghai, 200233, China
Completed
Shanghai, 200025, China
Completed
Shanghai, China
Completed
Shanghai, 200003, China
Completed
Beijing, 100005, China
Withdrawn
Beijing, 100034, China
Completed
Beijing, 100853, China
Completed
Chengdu, 610041, China
Completed
Shenyang, 110001, China
Completed
Shenyang, 110015, China
Completed
Changsha, 410013, China
Completed
Chongqing, 400042, China
Completed
Chongqing, 400038, China
Withdrawn
Changchun, China
Completed
Changchun, China
Completed
Jakarta, 10430, Indonesia
Completed
Surabaya, 60286, Indonesia
Completed
Seoul, 138736, Korea, Republic Of
Completed
Seoul, 135-710, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Vilnius, 10207, Lithuania
Completed
Vilnius, LT-2001, Lithuania
Completed
Beijing, 100853, China
Completed
Beijing, 100050, China
Completed
Guangzhou, 510120, China
Completed
Guangzhou, 510405, China
Completed
Guangzhou, China
Completed
Changsha, 410013, China
Completed
The 1st Affiliated Hosp of the 4th Military Med UniXi'an, 710032, China
Completed
The 1st Affiliated Hosp of the 4th Military Med UniXi'an, 710032, China
Completed
1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.Xi'an, 710061, China
Completed
Chongqing, 400042, China
Completed
Shenyang, 110004, China
Completed
1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.Xi'an, 710061, China
Completed
Shanghai, 200127, China
Completed
Vilnius, 04130, Lithuania
Completed
Kaunas, LT-3000, Lithuania
Completed
Kaunas, LT-3026, Lithuania
Completed
Utena, LT-28142, Lithuania
Completed
Klaipeda, LT-92231, Lithuania
Withdrawn
Zürich, 8091, Switzerland
Completed
Luzern, 6000, Switzerland
Withdrawn
Genève, 1211, Switzerland
Completed
Basel, 4031, Switzerland
Completed
Langenthal, 4901, Switzerland
Completed
Liestal, 4410, Switzerland
Completed
Helsinki, 00290, Finland
Withdrawn
Turku, 20520, Finland
Completed
Bangalore, 560052, India
Completed
Pune, 411011, India
Completed
Beijing, 100029, China
Completed
Beijing, 100037, China
Completed
Jakarta, 11420, Indonesia
Completed
Seoul Metropolitan Boramae HospitalSeoul, 156-707, Korea, Republic Of
Completed
Gyeonggi-do, 463-712, Korea, Republic Of
Completed
Gyeongi-do, 463-707, Korea, Republic Of
Completed
Jeollanam-do, 519-763, Korea, Republic Of
Completed
Kaunas, LT-3002, Lithuania
Completed
Siauliai, 76231, Lithuania
Completed
Klaipeda, LT-5800, Lithuania
Withdrawn
Baden, 5404, Switzerland
Completed
Bern, 3010, Switzerland
Completed
Bruderholz, 4101, Switzerland
Withdrawn
Bruderholz, 4101, Switzerland
Withdrawn
Lahti, 15850, Finland
Withdrawn
Hämeenlinna, 13530, Finland
Completed
Bangalore, 560099, India
Withdrawn
Thiruvananthapuram, 695002, India
Completed
Chennai, 600081, India
Withdrawn
Kolkata, 700 099, India
Completed
Mumbai, 400022, India
Completed
Tainan, 710, Taiwan
Completed
Tallinn, 13419, Estonia
Completed
Tallinn, EE-10617, Estonia
Completed
Lima, 31, Peru
Completed
Callao, CALLAO 2, Peru
Completed
Callao, CALLAO 2, Peru
Completed
Shatin, Hong Kong
Completed
Shatin, Hong Kong
Completed
Singapore, 169608, Singapore
Completed
Singapore, 168752, Singapore
Completed
Singapore, 308433, Singapore
Withdrawn
Jyväskylä, 40620, Finland
Completed
Raisio, 21200, Finland
Withdrawn
Turku, 20700, Finland
Withdrawn
Lappeenranta, 53130, Finland
Completed
Calicut, 673 004, India
Completed
Ahmedabad, 380 054, India
Completed
Hyderabad, 500034, India
Completed
Noida, India
Completed
Pune, 411001, India
Completed
Ludhiana, 141001, India
Completed
Hyderabad, 500082, India
Completed
Coimbatore, 641 004, India
Completed
Hyderabad, 600 038, India
Completed
Taipei, 10016, Taiwan
Completed
Kaohsiung, 833, Taiwan
Completed
Taipei, 114, Taiwan
Completed
Taipei, Taiwan
Completed
Singapore, 119074, Singapore
Completed
Changi General HospitalSingapore, 529889, Singapore
Completed
Singapore, 169608, Singapore
Completed
Auckland, 0622, New Zealand
Withdrawn
Christchurch, 8011, New Zealand
Completed
Bangkok, 10700, Thailand
Completed
Chiangmai, 50200, Thailand
Completed
Valmiera, LV-4201, Latvia
Completed
Liepaja, 3402, Latvia
Completed
Daugavpils, LV-5417, Latvia
Completed
Riga, LV-1005, Latvia
Withdrawn
Riga, LV-1038, Latvia
Withdrawn
Ventspils, LV-3601, Latvia
Completed
Ljubljana, 1000, Slovenia
Withdrawn
Ljubljana, 1000, Slovenia
Completed
Ljubljana, 1000, Slovenia
Withdrawn
Novo mesto, 8000, Slovenia
Completed
Tallinn, 10138, Estonia
Completed
Tartu, EE-51014, Estonia
Completed
Lima, LIMA 1, Peru
Completed
Lima, 01, Peru
Completed
Lima Cercado, LIMA 1, Peru
Completed
Lima, LIMA 11, Peru
Completed
Negeri Sembilan,, 70300, Malaysia
Completed
Sarawak, 93400, Malaysia
Completed
Kuala Lumpur, 59100, Malaysia
Completed
Auckland, 2024, New Zealand
Completed
Auckland, 1023, New Zealand
Completed
Bangkok, 10400, Thailand
Completed
Riga, LV-1001, Latvia
Completed
Riga, 1002, Latvia
Completed
Golnik, 4204, Slovenia
Completed
Ljubljana, 1000, Slovenia
Completed
Ljubljana, 1000, Slovenia
Completed
Ljubljana, 1000, Slovenia
Completed
Zagreb, 10000, Croatia
Completed
Zagreb, 10000, Croatia
Withdrawn
Zagreb, 10000, Croatia
Withdrawn
Rijeka, 51000, Croatia
Completed
Zagreb, 1000, Croatia
Completed
Lahore, Pakistan
Completed
Lahore, Pakistan
Completed
Karachi, 75500, Pakistan
Withdrawn
Bucharest, 022328, Romania
Withdrawn
Bucharest, 041915, Romania
Completed
KIRCHBERG, 2540, Luxembourg
Completed
NIEDERKORN, 4602, Luxembourg
Completed
Zagreb, 10000, Croatia
Completed
Zadar, 23000, Croatia
Completed
Osijek, 310 00, Croatia
Withdrawn
Karachi, 74800, Pakistan
Withdrawn
Bucharest, 014461, Romania
Withdrawn
Constanta, 900591, Romania
Withdrawn
Suceava, 720237, Romania
Withdrawn
LUXEMBOURG, 1210, Luxembourg

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to Day 35 + 6 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with composite endpoint of VTE (any DVT, non fatal PE) and VTE-related death up to Day 10 + 5 days
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants with composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days
    date_rangeTime Frame:
    Up to Day 35 + 6 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with VTE combined with all-cause mortality up to Day 10 + 5 days
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with symptomatic VTE, including and excluding VTE-related death up to Days 10, 35, and 90
    date_rangeTime Frame:
    At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to Day 35 + 6 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with major vascular events up to Days 10, 35, and 90
    date_rangeTime Frame:
    At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to Day 35 + 6 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with all-cause mortality up to Day 90 + 7 days
    date_rangeTime Frame:
    Up to Day 90 + 7 days
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to Day 35 + 6 days
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Up to Day 10 + 5 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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