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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Krankenhaus der Barmherzigen Schwestern Linz Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nordsjællands Hospital - Hørsholm Hørsholm, Denmark, DK-2970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kings College Hospital London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helse Blefjell Rjukan sykehus Rjukan, Norway, NO-3660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgem. öffentl. Krankenhaus Wiener Neustadt Wiener Neustadt, Austria, 2700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helios Klinikum Emil von Behring Berlin, Germany, 14165 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zerifin, Israel, 70300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lovisenberg Diakonale sykehus Oslo, Norway, 0440 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny AM w Bialymstoku Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Halmstad, Sweden, 301 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gentofte Hospital Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations RHMS Site Louis Caty BAUDOUR, Belgium, 7331 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Garmisch-Partenkirchen Garmisch-Partenkirchen, Germany, 82467 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Roger Salengro - Lille LILLE CEDEX, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario Monteluce Perugia, Italy, 06122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orbis Medisch Centrum SITTARD, Netherlands, 6131 BK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHR de Huy HUY, Belgium, 4500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Philipps-Universität Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regionshospitalet Silkeborg Silkeborg, Denmark, 8600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Nord - Amiens AMIENS, France, 80030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 1 Perugia - Umbria Gubbio, Italy, 06024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tergooiziekenhuizen Hilversum HILVERSUM, Netherlands, 1213 XZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Notodden sykehus Notodden, Norway, NO-3675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset Buskerud HF Drammen, Norway, NO-3019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. Rydygiera Krakow, Poland, 31-826 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kungälvs Sjukhus Kungälv, Sweden, 442 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kreiskrankenhaus Rheinfelden Rheinfelden, Germany, 79618 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 00-909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytet Medyczny Lodz, Poland, 91-425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopädische Universitätsklinik - Friedrichsheim Frankfurt, Germany, 60528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny nr 3 Gdansk, Poland, 80-742 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Ulm Ulm, Germany, 89075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Fürth Fürth, Germany, 90766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Donauspital im SMZ-Ost der Stadt Wien Wien, Austria, 1220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Brugmann/UVC Brugmann BRUXELLES - BRUSSEL, Belgium, 1020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herlev Hospital Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PolyClinique de la providence - Poitiers POITIERS, France, 86000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Maartenskliniek NIJMEGEN, Netherlands, 6522 JV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regionaal Ziekenhuis St-Trudo SINT-TRUIDEN, Belgium, 3800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Circolo e Fond.Macchi Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nordlandssykehuset HF Bodø, Norway, NO-8005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sana Kliniken Sommerfeld, Germany, 16766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Controlled, Double-Blind, Randomised, Dose-ranging Study on the Prevention of VTE in patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causesTimeframe: 5-9 days after surgery
Secondary Outcome
- Incidence of DVTs (total, proximal, distal)Timeframe: 5-9 days after surgery
- Incidence of symptomatic Venous Thrombo Embolisms (VTEs)Timeframe: 5-9 days after surgery
- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drugTimeframe: 40 days
- Healthcare Resource Utilisation QuestionnaireTimeframe: 9 days and 40 days after surgery
Additional Information
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