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

EU CT Number:

Not Available

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

November2004

July2005

Phase

Could I receive a placebo?

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Krankenhaus der Barmherzigen Schwestern Linz Linz, Austria, 4010	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kings College Hospital London, United Kingdom, SE5 9RS	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Donauspital im SMZ-Ost der Stadt Wien Wien, Austria, 1220	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Virga Jesse Ziekenhuis HASSELT, Belgium, 3500	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kreiskrankenhaus Rheinfelden Rheinfelden, Germany, 79618	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Institut Montsouris - Paris PARIS CEDEX 14, France, 75877	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Ravenscourt Park Hospital London, United Kingdom, W6 0TN	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations IRCCS Ist Clinico Humanitas Rozzano, Italy, 20089	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations St. Maartenskliniek NIJMEGEN, Netherlands, 6522 JV	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kungälvs Sjukhus Kungälv, Sweden, 442 83	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Clinique les Maussins-Nollet - Paris PARIS CEDEX 19, France, 75019	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nordsjællands Hospital - Hørsholm Hørsholm, Denmark, DK-2970	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations PolyClinique de la providence - Poitiers POITIERS, France, 86000	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Rambam Medical Center Haifa, Israel, 31096	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations AUSL 1 Perugia - Umbria Gubbio, Italy, 06024	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tergooiziekenhuizen Hilversum HILVERSUM, Netherlands, 1213 XZ	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Helse Blefjell Rjukan sykehus Rjukan, Norway, NO-3660	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations SU/Östra Göteborg, Sweden, 416 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Regionshospitalet Silkeborg Silkeborg, Denmark, 8600	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Assaf Harofeh Medical Center Zerifin, Israel, 70300	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Notodden sykehus Notodden, Norway, NO-3675	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Allgem. öffentl. Krankenhaus Wiener Neustadt Wiener Neustadt, Austria, 2700	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Klinikum Garmisch-Partenkirchen Garmisch-Partenkirchen, Germany, 82467	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Lovisenberg Diakonale sykehus Oslo, Norway, 0440	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Länssjukhuset Halmstad, Sweden, 301 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Imeldaziekenhuis - St-Elisabethkliniek BONHEIDEN, Belgium, 2820	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Sana Kliniken Sommerfeld, Germany, 16766	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Edith Wolfson Medical Center Holon, Israel, 58100	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations A.O. San Gerardo di Monza Monza, Italy, 20052	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 00-909	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Rabin Medical Center, Campus Golda Petach Tikva, Israel, 49372	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Istituto Ortopedico G.Pini Milano, Italy, 20122	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Szpital Kliniczny nr 3 Gdansk, Poland, 80-742	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Asklepios Klinikum Melsungen Melsungen, Germany, 34212	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Herlev Hospital Herlev, Denmark, 2730	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Spaarne Ziekenhuis HOOFDDORP, Netherlands, 2134 TM	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations SP Szpital Kliniczny AM w Bialymstoku Bialystok, Poland, 15-276	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations A.ö. Krankenhaus der Stadt Linz Linz, Austria, 4020	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Gentofte Hospital Hellerup, Denmark, 2900	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Polyclinique de l'Atlantique - Saint Herblain SAINT HERBLAIN, France, 44819	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Sapir Medical Center, Meir General Hospital Kfar Saba, Israel, 44281	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations IRCCS Ist Ortopedico Rizzoli Bologna, Italy, 40136	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Wojewodzki Szpital Specjalistyczny im. Rydygiera Krakow, Poland, 31-826	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Klinikum Fürth Fürth, Germany, 90766	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Orthopädische Universitätsklinik - Friedrichsheim Frankfurt, Germany, 60528	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Klinikum der Philipps-Universität Marburg, Germany, 35043	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Locations

Status

Locations

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria, 4010

Status

Completed

Contact Us:

Venous Thromboembolism

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information