Trial Condition(s):

Venous Thromboembolism

Dose-ranging study of once-daily regimen of BAY 59-7939 in the prevention of VTE in patients undergoing elective total Hip replacement (ODIXaHIP-OD)

Bayer Identifier:

11527

ClinicalTrials.gov Identifier:

NCT00396786

EudraCT Number:

2004-001341-14

Study Completed

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.

Inclusion Criteria
- Male patients aged 18 years or above and postmenopausal female patients
 - Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis)
 - Patients written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures
Exclusion Criteria
- Related to medical history:
 -- Any VTE prior to randomization
 -- Myocardial infarction (MI) or TIA or ischaemic stroke within the last 6 months prior to randomisation
 -- History of heparin-induced thrombocytopenia, allergy to heparins- Intracerebral or intraocular bleeding within the last 6 months prior to randomisation
 - History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study
 - History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug (e.g. severe active inflammatory bowel disease, short gut syndrome)
 - Amputation of one legRelated to current symptoms or findings:
 --  Heart insufficiency NYHA class III-IV- Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits) including patients with acquired or congenital thrombopathy
 --  Thrombocytopenia (platelets < 100.000/µl)- Macroscopic haematuria- Allergy to contrast media- Severe hypertension (SBP > 200 mmHg, DBP > 100 mmHg)- Impaired liver function (transaminases > 2 x ULN)
 --  Impaired renal function (serum creatinine > 1.5 x ULN or creatinine clearance < 30 ml/min)
 --  Active malignant disease - Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding- Body weight < 45 kg
 --  Drug- or alcohol abuse- Related to current treatment- Patients who cannot stop therapy (in the opinion of the investigator/physician) with anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) should be excluded from the study
 --  Fibrinolytic therapy- Therapy with acetylic salicylic acid or other platelet aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment. Patients not able to stop ASA therapy will be excluded
 --  All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs) will be not allowed during the study treatment period- Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole) and other strong CYP3A4-inhibitors eg HIV-protease inhibitors. Azole compounds and other strong CYP3A4-inhibitors eg HIV-protease should be stopped at least four days before enrolment
 - Therapy with another investigational product within 30 days prior start of study
 - Miscellaneous
 - Planned intermittent pneumatic compression during active treatment period
 - Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed)
 - If traumatic or repeated epidural and spinal puncture occur the patient should be excluded from study
 - Concomitant participation in another trial or study

Trial Summary

Enrollment Goal
877
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria, 4010

Status
Completed
 
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

Städtische Kliniken Frankfurt am Main / Hoechst

Frankfurt, Germany, 65929

Status
Completed
 
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Terminated
 
Locations

Donauspital im SMZ-Ost der Stadt Wien

Wien, Austria, 1220

Status
Completed
 
Locations

Virga Jesse Ziekenhuis

HASSELT, Belgium, 3500

Status
Completed
 
Locations

Kreiskrankenhaus Rheinfelden

Rheinfelden, Germany, 79618

Status
Completed
 
Locations

Institut Montsouris - Paris

PARIS CEDEX 14, France, 75877

Status
Terminated
 
Locations

Ravenscourt Park Hospital

London, United Kingdom, W6 0TN

Status
Terminated
 
Locations

IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

St. Maartenskliniek

NIJMEGEN, Netherlands, 6522 JV

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

Kungälvs Sjukhus

Kungälv, Sweden, 442 83

Status
Completed
 
Locations

Clinique les Maussins-Nollet - Paris

PARIS CEDEX 19, France, 75019

Status
Terminated
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Nordsjællands Hospital - Hørsholm

Hørsholm, Denmark, DK-2970

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

PolyClinique de la providence - Poitiers

POITIERS, France, 86000

Status
Terminated
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

AUSL 1 Perugia - Umbria

Gubbio, Italy, 06024

Status
Completed
 
Locations

Tergooiziekenhuizen Hilversum

HILVERSUM, Netherlands, 1213 XZ

Status
Completed
 
Locations

Helse Blefjell Rjukan sykehus

Rjukan, Norway, NO-3660

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Terminated
 
Locations

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Status
Completed
 
Locations

Notodden sykehus

Notodden, Norway, NO-3675

Status
Completed
 
Locations

Allgem. öffentl. Krankenhaus Wiener Neustadt

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Status
Completed
 
Locations

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany, 82467

Status
Terminated
 
Locations

Lovisenberg Diakonale sykehus

Oslo, Norway, 0440

Status
Completed
 
Locations

Länssjukhuset

Halmstad, Sweden, 301 85

Status
Completed
 
Locations

Imeldaziekenhuis - St-Elisabethkliniek

BONHEIDEN, Belgium, 2820

Status
Terminated
 
Locations

Sana Kliniken

Sommerfeld, Germany, 16766

Status
Completed
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Completed
 
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

Status
Completed
 
Locations

Rabin Medical Center, Campus Golda

Petach Tikva, Israel, 49372

Status
Terminated
 
Locations

Istituto Ortopedico G.Pini

Milano, Italy, 20122

Status
Terminated
 
Locations

Szpital Kliniczny nr 3

Gdansk, Poland, 80-742

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Asklepios Klinikum Melsungen

Melsungen, Germany, 34212

Status
Terminated
 
Locations

Herlev Hospital

Herlev, Denmark, 2730

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebrón

Barcelona, Spain, 08035

Status
Terminated
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Terminated
 
Locations

Spaarne Ziekenhuis

HOOFDDORP, Netherlands, 2134 TM

Status
Completed
 
Locations

SP Szpital Kliniczny AM w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

A.ö. Krankenhaus der Stadt Linz

Linz, Austria, 4020

Status
Completed
 
Locations

Gentofte Hospital

Hellerup, Denmark, 2900

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Polyclinique de l'Atlantique - Saint Herblain

SAINT HERBLAIN, France, 44819

Status
Terminated
 
Locations

Sapir Medical Center, Meir General Hospital

Kfar Saba, Israel, 44281

Status
Completed
 
Locations

IRCCS Ist Ortopedico Rizzoli

Bologna, Italy, 40136

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. Rydygiera

Krakow, Poland, 31-826

Status
Completed
 
Locations

Klinikum Fürth

Fürth, Germany, 90766

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Orthopädische Universitätsklinik - Friedrichsheim

Frankfurt, Germany, 60528

Status
Completed
 
Locations

Klinikum der Philipps-Universität

Marburg, Germany, 35043

Status
Completed
 

Trial Design