check_circleStudy Completed
Venous Thromboembolism
Bayer Identifier:
11527
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Dose-ranging study of once-daily regimen of BAY 59-7939 in the prevention of VTE in patients undergoing elective total Hip replacement
Trial purpose
The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
877Trial Dates
November 2004 - July 2005Phase
Phase 2Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Krankenhaus der Barmherzigen Schwestern Linz | Linz, 4010, Austria |
Completed | Ziekenhuis Oost-Limburg | GENK, 3600, Belgium |
Completed | Städtische Kliniken Frankfurt am Main / Hoechst | Frankfurt, 65929, Germany |
Terminated | Kings College Hospital | London, SE5 9RS, United Kingdom |
Completed | Donauspital im SMZ-Ost der Stadt Wien | Wien, 1220, Austria |
Completed | Virga Jesse Ziekenhuis | HASSELT, 3500, Belgium |
Completed | Kreiskrankenhaus Rheinfelden | Rheinfelden, 79618, Germany |
Terminated | Institut Montsouris - Paris | PARIS CEDEX 14, 75877, France |
Terminated | Ravenscourt Park Hospital | London, W6 0TN, United Kingdom |
Completed | IRCCS Ist Clinico Humanitas | Rozzano, 20089, Italy |
Completed | St. Maartenskliniek | NIJMEGEN, 6522 JV, Netherlands |
Completed | Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ | Lublin, 20-718, Poland |
Completed | Kungälvs Sjukhus | Kungälv, 442 83, Sweden |
Terminated | Clinique les Maussins-Nollet - Paris | PARIS CEDEX 19, 75019, France |
Completed | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Completed | Nordsjællands Hospital - Hørsholm | Hørsholm, DK-2970, Denmark |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Terminated | PolyClinique de la providence - Poitiers | POITIERS, 86000, France |
Completed | Rambam Medical Center | Haifa, 31096, Israel |
Completed | AUSL 1 Perugia - Umbria | Gubbio, 06024, Italy |
Completed | Tergooiziekenhuizen Hilversum | HILVERSUM, 1213 XZ, Netherlands |
Completed | Helse Blefjell Rjukan sykehus | Rjukan, NO-3660, Norway |
Completed | Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin, 20-090, Poland |
Completed | SU/Östra | Göteborg, 416 85, Sweden |
Completed | Regionshospitalet Silkeborg | Silkeborg, 8600, Denmark |
Terminated | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Assaf Harofeh Medical Center | Zerifin, 70300, Israel |
Completed | Notodden sykehus | Notodden, NO-3675, Norway |
Completed | Allgem. öffentl. Krankenhaus Wiener Neustadt | Wiener Neustadt, 2700, Austria |
Completed | ZNA Middelheim | ANTWERPEN, 2020, Belgium |
Terminated | Klinikum Garmisch-Partenkirchen | Garmisch-Partenkirchen, 82467, Germany |
Completed | Lovisenberg Diakonale sykehus | Oslo, 0440, Norway |
Completed | Länssjukhuset | Halmstad, 301 85, Sweden |
Terminated | Imeldaziekenhuis - St-Elisabethkliniek | BONHEIDEN, 2820, Belgium |
Completed | Sana Kliniken | Sommerfeld, 16766, Germany |
Completed | Länssjukhuset Ryhov | Jönköping, 551 85, Sweden |
Completed | Edith Wolfson Medical Center | Holon, 58100, Israel |
Completed | A.O. San Gerardo di Monza | Monza, 20052, Italy |
Completed | Wojskowy Instytut Medyczny | Warszawa, 00-909, Poland |
Terminated | Rabin Medical Center, Campus Golda | Petach Tikva, 49372, Israel |
Terminated | Istituto Ortopedico G.Pini | Milano, 20122, Italy |
Completed | Szpital Kliniczny nr 3 | Gdansk, 80-742, Poland |
Completed | Rabin Medical Center - Beilinson Campus | Petach Tikva, 49100, Israel |
Completed | Medizinische Einrichtungen der Heinrich-Heine-Universität | Düsseldorf, 40225, Germany |
Terminated | Asklepios Klinikum Melsungen | Melsungen, 34212, Germany |
Completed | Herlev Hospital | Herlev, 2730, Denmark |
Terminated | Ciutat Sanitària i Universitaria de la Vall d'Hebrón | Barcelona, 08035, Spain |
Terminated | Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel |
Completed | Spaarne Ziekenhuis | HOOFDDORP, 2134 TM, Netherlands |
Completed | SP Szpital Kliniczny AM w Bialymstoku | Bialystok, 15-276, Poland |
Completed | A.ö. Krankenhaus der Stadt Linz | Linz, 4020, Austria |
Completed | Gentofte Hospital | Hellerup, 2900, Denmark |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Terminated | Polyclinique de l'Atlantique - Saint Herblain | SAINT HERBLAIN, 44819, France |
Completed | Sapir Medical Center, Meir General Hospital | Kfar Saba, 44281, Israel |
Completed | IRCCS Ist Ortopedico Rizzoli | Bologna, 40136, Italy |
Completed | Wojewodzki Szpital Specjalistyczny im. Rydygiera | Krakow, 31-826, Poland |
Completed | Klinikum Fürth | Fürth, 90766, Germany |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Orthopädische Universitätsklinik - Friedrichsheim | Frankfurt, 60528, Germany |
Completed | Klinikum der Philipps-Universität | Marburg, 35043, Germany |
Primary Outcome
- Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causesdate_rangeTime Frame:6-10 days after surgeryenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Incidence of DVTs (total, proximal, distal)date_rangeTime Frame:6-10 days after surgeryenhanced_encryptionNoneSafety Issue:
- Incidence of symptomatic Venous Thrombo Embolisms (VTEs)date_rangeTime Frame:6-10 days after surgeryenhanced_encryptionNoneSafety Issue:
- Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)date_rangeTime Frame:6-10 days after surgeryenhanced_encryptionNoneSafety Issue:
- The composite endpoint that results from the primary endpoint by substituting VTE related death for all deathdate_rangeTime Frame:40 daysenhanced_encryptionNoneSafety Issue:
- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drugdate_rangeTime Frame:40 daysenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6Additional Information
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