Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
ODIXa-HIP2
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
1 other identifier
interventional
726
13 countries
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2004
Shorter than P25 for phase_2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 7, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedMay 8, 2009
May 1, 2009
November 7, 2006
May 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes
5-9 days after surgery
Secondary Outcomes (4)
Incidence of DVTs (total, proximal, distal)
5-9 days after surgery
Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
5-9 days after surgery
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug
40 days
Healthcare Resource Utilisation Questionnaire
9 days and 40 days after surgery
Study Arms (6)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
EXPERIMENTALArm 5
EXPERIMENTALArm 6
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (61)
Unknown Facility
Wiener Neustadt, Lower Austria, 2700, Austria
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Linz, Upper Austria, 4010, Austria
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Vienna, Vienna, 1220, Austria
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Baudour, 7331, Belgium
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Bruxelles - Brussel, 1020, Belgium
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Genk, 3600, Belgium
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Huy, 4500, Belgium
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Sint-Truiden, 3800, Belgium
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Hellerup, 2900, Denmark
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Herlev, 2730, Denmark
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Hørsholm, DK-2970, Denmark
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Silkeborg, 8600, Denmark
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Amiens, 80030, France
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Lille, 59037, France
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Poitiers, 86000, France
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Rheinfelden, Baden-Wurttemberg, 79618, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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Fürth, Bavaria, 90766, Germany
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Garmisch-Partenkirchen, Bavaria, 82467, Germany
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Sommerfeld, Brandenburg, 16766, Germany
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Frankfurt am Main, Hesse, 60528, Germany
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Frankfurt am Main, Hesse, 65929, Germany
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Marburg, Hesse, 35043, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Dresden, Saxony, 01307, Germany
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Berlin, State of Berlin, 14165, Germany
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Haifa, 31096, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Rozzano, Milano, 20089, Italy
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Gubbio, Perugia, 06024, Italy
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Milan, 20132, Italy
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Pavia, 27100, Italy
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Perugia, 06122, Italy
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Reggio Emilia, 42100, Italy
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Varese, 21100, Italy
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Hilversum, 1213 XZ, Netherlands
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Nijmegen, 6522 JV, Netherlands
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Sittard, 6131 BK, Netherlands
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Bodø, NO-8005, Norway
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Drammen, NO-3019, Norway
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Notodden, NO-3675, Norway
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Oslo, 0440, Norway
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Rjukan, NO-3660, Norway
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Bialystok, 15-276, Poland
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Gdansk, 80-742, Poland
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Krakow, 31-826, Poland
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Lodz, 91-425, Poland
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Lublin, 20-090, Poland
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Lublin, 20-718, Poland
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Warsaw, 00-909, Poland
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Badalona, Barcelona, 08916, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Valencia, Valencia, 46010, Spain
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Gothenburg, 416 85, Sweden
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Halmstad, 301 85, Sweden
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Jönköping, 551 85, Sweden
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Kungälv, 442 83, Sweden
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London, Greater London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2006
First Posted
November 14, 2006
Study Start
January 1, 2004
Study Completion
September 1, 2004
Last Updated
May 8, 2009
Record last verified: 2009-05