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    Summary
    EudraCT Number:2004-001083-43
    Sponsor's Protocol Code Number:BAY 59-7939 / 11223
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-001083-43
    A.3Full title of the trial
    Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis
    ODIXa-DVT
    A prospective, randomized, multinational, multicenter, partially blinded, parallel-group, open-label active comparator controlled phase II Dose Finding and Proof of Principle Trial.
    A.3.2Name or abbreviated title of the trial where available
    ODIXa-DVT
    A.4.1Sponsor's protocol code numberBAY 59-7939 / 11223
    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 INNproposed INN: rivaroxaban
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 100 mg Clexane 80 mg Clexane 60 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute deep vein thrombosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level Code
    E.1.2Classification code 10051055
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this Phase II dose finding trial are to assess the efficacy and safety of BAY 59-7939 for the treatment of acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound - CCUS) in male and female patients aged 18 years or above. Patients with symptomatic pulmonary embolism at study entry will be excluded.
    Pharmacokinetic and pharmacodynamic parameters (incl, activated partial thrombin time (aPTT), prothrombin time (PT, INR) Factor Xa activity 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 and female patients aged 18 years or above (For women with childbearing potential pregnancy has to be excluded prior randomization. Females with childbearing potential must use adequate contraception method during the study).
     Patients with acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound).
     Patients must have signed an informed consent form for participation prior to study entry (after receiving detailed written and oral previous information to any study specific procedures)
    E.4Principal exclusion criteria
    Related to medical history
     TIA or ischemic stroke within the last 6 months prior to study entry.
     History of heparin-induced thrombocytopenia, allergy to heparins.
     Intracerebral or intraocular bleeding within the last 6 months prior to study entry.
     History of 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 (eg severe inflammatory bowel disease, short gut syndrome).
    Related to current symptoms or findings
     Female with childbearing potential using no adequate contraception method.
    (NOTE: As adequate method of birth control oral contraception is recommended. If oral contraception is not feasible or not recommended according to local guidelines both partners should use adequate barrier birth control).
     Pregnant and breastfeeding women.
     Symptomatic pulmonary embolism.
     Surgery either major or minor within the last 10 days.
     Neurosurgery within the last 4 weeks
     Heart insufficiency NYHA III-IV.
     Bacterial endocarditis.
     Known congenital or acquired hemorrhagic diathesis (INR / aPTT not within normal limits) including patients with acquired or congenital thrombopathy.
     Thrombocytopenia (platelets < 100.000/l).
     Macroscopic hematuria.
     Uncontrolled 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 clearence
    < 30 ml/min).
    (NOTE: If a patient meet the exclusion criteria regarding renal impairment during the study (serum creatinine > 1.5 x ULN or creatinine clearance < 30 ml/min) and this is confirmed by two consecutive measurements within 24 hours the patient should stop intake of study medication).
     Patients with known brain metastases.
     Patients receiving cytotoxic chemotherapy.
     Life-expectancy < 6 months.
     Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding or any other increased risk for bleeding (eg diabetic retinopathy).
     Body weight < 45 kg.
     Drug-or alcohol abuse.

    Related to current treatment
     Therapy with oral anticoagulants, heparins or factor Xa inhibitors other than study medication are not allowed.
     Therapy with acetylicsalicylic acid or other platelet aggregation inhibitors (eg clopidogrel, dipyridamole and ticlopidine) must be stopped prior to randomization. Patients where continued treatment with acetylicsalicylic acid or other platelet aggregation inhibitors is clinically indicated will be excluded.
     Any treatment prior to randomization with heparins (exception: unfractionated heparin treatment within 36 hours, 2 therapeutic doses of a LMWH 24 hours apart or 3 therapeutic doses of a LMWH 12 hours apart. Prophylactic doses of UFH or LMWH are allowed).
     Fibrinolytic agents are not allowed during the study.
     All other drugs influencing coagulation (exception: NSAIDs with half-life < 17 hours) are not allowed during the study.
     Systemic and local topical treatment with azole compounds (eg ketoconazol, fluconazol, itraconazol) and other strong CYP3A4 inhibitors (eg HIV protease inhibitors). Azole compounds and other strong CYP3A4 inhibitors are not allowed within 4 days prior to randomization and during the study.

    Miscellaneous
     Concomitant participation in another trial or study.
     Therapy with another investigational product within 30 days prior start of study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the response to treatment as determined by CCUS after three weeks of treatment. A positive response is defined as an improvement in the CCUS score compared to baseline. However, any confirmed symptomatic recurrence of extension of DVT, any confirmed symptomatic PE or any VTE-related death up to Day 21 defines a negative response even in case of an improved CCUS at Day 21

    Secondary efficacy endpoints are:
     Response to treatment at Day 21 as determined by CCUS and perfusion lung scan where a positive response is defined as an improvement in the CCUS and /or perfusion lung scan without any deterioration in either.
     Response to treatment at Day 84 as assessed by CCUS.
     Residual vein diameter as assessed by CCUS on Day 84.
     Incidence of symptomatic and confirmed recurrence or extension of DVT during the 3 months treatment period.
     Incidence of symptomatic and confirmed PE during the 3 months treatment period.
     Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period.
     Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths related to VTE during the 3 months treatment period.
     Incidence of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE within 30 days after stop of treatment with study drug.

    The analysis of the primary and secondary efficacy endpoints will solely be based on the assessments made by the adjudication committees.

    A further secondary efficacy endpoint is health care resource utilization (HCRU), assessed by duration of hospitalization and any re-hospitalization during the entire study period, rehabilitation center stay following hospital discharge, physician and nurse consultations excluding study visits, and frequency of vitamin K-antagonist monitoring (INR) following discharge from hospital and until the end of Follow-up.


    Safety Variables

    The primary safety endpoint will be the incidence of treatment-emergent major bleeding events starting not later than 7 days after last intake of study drug. Major bleeding observed after this period will be considered separately. The analysis of the primary safety endpoint will solely be based on the classification made by the Adjudication Committee.

    Other safety variables are:
     Incidence of minor bleeding events
     Treatment-emergent adverse events
     Treatment-emergent serious adverse events
     Deaths
     Adverse events starting more than 7 days after stop of treatment
     Incidence of (prolonged) hospitalization
     Transfusion requirements
     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 Information not present in EudraCT
    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 and Proof of principle
    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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    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
    randomized, partially blinded, parallel-group, open-label 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 Information not present in EudraCT
    E.8.2.3.1Comparator description
    Enoxaparin-Na
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-10-21. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 600
    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 Decision2004-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-10-05
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