Trial Condition(s):

Venous Thromboembolism

Dose-ranging Study of BAY 59-7939 on the Prevention of VTE in patients Undergoing Elective Total Hip Replacement (ODIXa-HIP2)

Bayer Identifier:

10944

ClinicalTrials.gov Identifier:

NCT00398905

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

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
- 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 leg
- Heart insufficiency NYHA 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 > 200mmHg, 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
- 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) and fibrinolytic therapy should be excluded from the study
- Therapy with acetylic salicylic acid or other thrombocyte 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 allowed)
- Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole) and other strong CYP3A4 inhibitors e.g. HIV-protease inhibitors. Azole compounds and other strong CYP3A4 inhibitors
- Therapy with another investigational product within 30 days prior start of study
- Planned intermittent pneumatic compression during active treatment period
- Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed)
- Concomitant participation in another trial or study

Trial Summary

Enrollment Goal
726
Trial Dates
black-arrow
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

Nordsjællands Hospital - Hørsholm

Hørsholm, Denmark, DK-2970

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Helse Blefjell Rjukan sykehus

Rjukan, Norway, NO-3660

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Allgem. öffentl. Krankenhaus Wiener Neustadt

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Helios Klinikum Emil von Behring

Berlin, Germany, 14165

Status
Terminated
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Status
Completed
 
Locations

Lovisenberg Diakonale sykehus

Oslo, Norway, 0440

Status
Completed
 
Locations

SP Szpital Kliniczny AM w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Länssjukhuset

Halmstad, Sweden, 301 85

Status
Completed
 
Locations

Gentofte Hospital

Hellerup, Denmark, 2900

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

RHMS Site Louis Caty

BAUDOUR, Belgium, 7331

Status
Terminated
 
Locations

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany, 82467

Status
Completed
 
Locations

Hopital Roger Salengro - Lille

LILLE CEDEX, France, 59037

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Policlinico Universitario Monteluce

Perugia, Italy, 06122

Status
Terminated
 
Locations

Orbis Medisch Centrum

SITTARD, Netherlands, 6131 BK

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Completed
 
Locations

CHR de Huy

HUY, Belgium, 4500

Status
Terminated
 
Locations

Klinikum der Philipps-Universität

Marburg, Germany, 35043

Status
Terminated
 
Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebrón

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hôpital Nord - Amiens

AMIENS, France, 80030

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

AUSL 1 Perugia - Umbria

Gubbio, Italy, 06024

Status
Completed
 
Locations

Tergooiziekenhuizen Hilversum

HILVERSUM, Netherlands, 1213 XZ

Status
Completed
 
Locations

Notodden sykehus

Notodden, Norway, NO-3675

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Sykehuset Buskerud HF

Drammen, Norway, NO-3019

Status
Terminated
 
Locations

Wojewodzki Szpital Specjalistyczny im. Rydygiera

Krakow, Poland, 31-826

Status
Completed
 
Locations

Kungälvs Sjukhus

Kungälv, Sweden, 442 83

Status
Completed
 
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

Kreiskrankenhaus Rheinfelden

Rheinfelden, Germany, 79618

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

Status
Completed
 
Locations

Städtische Kliniken Frankfurt am Main / Hoechst

Frankfurt, Germany, 65929

Status
Completed
 
Locations

Uniwersytet Medyczny

Lodz, Poland, 91-425

Status
Terminated
 
Locations

Orthopädische Universitätsklinik - Friedrichsheim

Frankfurt, Germany, 60528

Status
Completed
 
Locations

Szpital Kliniczny nr 3

Gdansk, Poland, 80-742

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Terminated
 
Locations

Klinikum Fürth

Fürth, Germany, 90766

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Terminated
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

Donauspital im SMZ-Ost der Stadt Wien

Wien, Austria, 1220

Status
Completed
 
Locations

CHU Brugmann/UVC Brugmann

BRUXELLES - BRUSSEL, Belgium, 1020

Status
Terminated
 
Locations

Herlev Hospital

Herlev, Denmark, 2730

Status
Terminated
 
Locations

PolyClinique de la providence - Poitiers

POITIERS, France, 86000

Status
Completed
 
Locations

IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

St. Maartenskliniek

NIJMEGEN, Netherlands, 6522 JV

Status
Completed
 
Locations

Regionaal Ziekenhuis St-Trudo

SINT-TRUIDEN, Belgium, 3800

Status
Terminated
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Completed
 
Locations

Nordlandssykehuset HF

Bodø, Norway, NO-8005

Status
Terminated
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Terminated
 
Locations

Sana Kliniken

Sommerfeld, Germany, 16766

Status
Completed
 

Trial Design