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    Summary
    EudraCT Number:2004-001341-14
    Sponsor's Protocol Code Number:BAY 59-7939 / 11527
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2004-001341-14
    A.3Full title of the trial
    Controlled, Double-Blind, Randomized, Dose-ranging Study of once-daily regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement-ODIXaHIP-OD Study
    A.3.2Name or abbreviated title of the trial where available
    ODIXaHIP-OD
    A.4.1Sponsor's protocol code numberBAY 59-7939 / 11527
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN/A
    D.3.2Product code BAY 59-7939
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrivaroxaban
    D.3.9.1CAS number 366789-02-8
    D.3.9.3Other descriptive name2-Thiophenecarboxamide, 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]met
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10, 20, 30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Clexane 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameClexane
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparin-Na
    D.3.9.1CAS number N/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeLow-molecular-weight heparin
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Deep Venous Thrombosis prophlaxis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Classification code 10012108
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this dose-ranging trial is to assess the efficacy and safety of BAY 59-7939 10 mg – 40 mg once daily dosing in prevention of VTE in men and in postmenopausal women aged 18 years or above undergoing elective primary total hip replacement. Population pharmacokinetics and pharmacodynamics (Factor Xa activity, PT, PT INR, aPTT and HepTest) will also be assessed.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    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 leg.
    Related 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 > 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.
    Related to current treatment
    - Patients who cannot stop therapy (in the opinion of the investigator/physician) with anticoagulants (eg 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. ketoconazol, fluconazol, itraconazol) and otherstrong 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.
    E.4Principal exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a composite endpoint of:
    - Any DVT (proximal and/or distal) and
    - Non fatal PE and
    - Death from all causes.
    - The primary endpoint will be evaluated 6 - 10 days after surgery (or in case of symptoms indicating VTE). The analysis of the primary efficacy endpoint will be solely based on the assessments made by the Venography and the VTE Adjudication Committees.

    Secondary efficacy endpoints are:
    - Incidence of DVTs (total, proximal, distal)
    - Incidence of symptomatic VTEs
    - Incidence of major VTE (ie. Proximal DVT, PE or VTE-related death)
    - The composite endpoint that results from the primary endpoint by substituting VTE related death for all death
    - Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.
    - The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessments made by the venography and VTE Adjudication committees.
    Safety Variables
    - The main safety endpoint is the incidence of major bleeding observed after the first post-operative intake of study drug and not later than 2 days after last intake of study drug. Major bleeding observed before or after this period will be considered separately.
    - The analysis of the primary safety endpoint will solely be based on the classification made by the Bleeding Adjudication Committee.

    Other safety variables are:
    - Incidence of non-major bleeding (clinically significant and minor bleeding)
    - Treatment-emergent adverse events
    - Treatment-emergent serious adverse events
    - Deaths
    - Adverse events starting more than 7 days after stop of treatment
    - Incidence of (prolonged) hospitalisation
    - Transfusion requirements (heterologous and autologous transfusions).
    - Amount of blood loss (intraoperative blood loss)
    - Post-operative volume in drainage
    - Laboratory parameters.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    parallel-group, active comparator controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 670
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
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