Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-004614-14
    Sponsor's Protocol Code Number:BAY 59-7939/12839
    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:2008-06-05
    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 number2007-004614-14
    A.3Full title of the trial
    MAGELLAN - Multicenter, rAndomized, parallel Group Efficacy superiority study in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin
    A.3.2Name or abbreviated title of the trial where available
    MAGELLAN
    A.4.1Sponsor's protocol code numberBAY 59-7939/12839
    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 No
    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 nameRivaroxaban
    D.3.2Product code BAY 59-7939
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.3Other descriptive name5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene...
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.2.1.1.1Trade name Clexane 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
    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 nameEnoxaparin
    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 sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 placeboFilm-coated tablet
    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
    Prevention of venous thromboembolism in patients who have been hospitalized for a medical illness
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10012108
    E.1.2Term Deep venous thrombosis prophylaxis
    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 study is to demonstrate the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days in men and women aged 40 years or above who have been hospitalized for a medical illness. The safety of rivaroxaban and enoxaparin will be compared as well.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged 40 years or more
    2. Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions such as:
    • Heart failure, NYHA class III or IV
    • Active cancer (eg, admitted for chemotherapy or for treatment of a complication of the active cancer)
    • Acute ischemic stroke (documented) with leg paresis or paralysis and inability to walk without assistance
    • Acute infection
    • Acute respiratory insufficiency
    • Acute rheumatic disorders
    • Acute inflammatory bowel disease
    • Diabetes mellitus (eg, diabetic ketoacidosis, hyperosmolar coma), pancreatitis (surgical management not planned), cholecystitis (surgical management not planned)
    • Other
    3. Anticipated complete immobilization during the first day of hospitalization and anticipated decreased level of mobility (bed rest) and hospital stay duration of at least 4 days
    4. Hospitalized less than 48 hours before randomization
    5. Patients’ written informed consent for participation after receiving detailed written and oral information prior to any study specific procedures
    E.4Principal exclusion criteria
    1. Conditions that contraindicate the use of antithrombotic therapy with the LMWH enoxaparin
    2. Conditions that may increase the risk of bleeding, including intracranial hemorrhage, such as:
    • Clinically significant bleeding, within 30 days of randomization
    • Platelet count < 100 x 10^9/L
    • Major surgery, biopsy of a parenchymal organ, ophthalmic surgery, or serious trauma within 6 weeks before randomization
    • A presenting diagnosis for which surgery is intended during hospitalization (eg, cholecystitis and planned cholecystectomy)
    • Have a known coagulopathy or bleeding diathesis (eg, disseminated intravascular coagulation) or an international normalized ratio (INR) known to be > 1.5 at the time of screening unrelated to VKA therapy
    • History of hemorrhagic stroke at any time in the past, evidence of primary intracranial hemorrhage on CT or MRI scan of the brain, or clinical presentation consistent with intracranial hemorrhage (eg, severe headache or new neurologic deficit after fibrinolytic therapy)
    • Recent severe head trauma within 30 days of randomization which includes concussion, skull fracture, or hospitalization for head injury
    • Known intracranial neoplasm, cerebral metastases, arteriovenous malformation, or aneurysm
    3. Required drugs or procedures, such as:
    • More than 2 days of prophylactic use of anticoagulants. Up to 2 doses of LMWH or up to 6 doses of unfractionated heparin pre-randomization are allowed.
    • Systemic treatment with more than 2 doses of strong inhibitors of cytochrome P450 3A4 (CYP 3A4), such as ketoconazole or protease inhibitors, within 4 days before randomization or planned treatment during the time period of the study drug administration
    • Indication for fibrinolysis or need for continued treatment with anticoagulant agents
    • Treatment with or use of mechanical thromboprophylaxis (eg, pneumatic compression devices, foot pumps) for VTE prevention
    4. Concomitant conditions or diseases, such as:
    • Known allergy to rivaroxaban or any of its excipients
    • Renal dysfunction (ie, calculated creatinine clearance <30 mL/min, Cockcroft-Gault formula)
    • Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis), or LFT abnormalities (confirmed with repeat testing) which would require study medication discontinuation, ie, ALT > 5 x ULN or ALT > 3 x ULN plus total bilirubin > 2 x ULN and the ratio of direct to total bilirubin ≥ 50%
    • Known human immunodeficiency virus (HIV) infection at screening
    • Sustained uncontrolled systolic blood pressure of ≥ 180 mmHg or diastolic pressure of ≥ 100 mmHg at time of screening despite treatment
    • Anemia (ie, hemoglobin < 10 g/dL) at the time of screening
    • History of ongoing drug or alcohol abuse
    • Cardiogenic or septic shock with the need for vasopressor(s), such as noradrenaline, and/or inotropes, such as dobutamine or milrinone
    • Any severe condition that would limit life expectancy to less than 6 months, ie, advanced malignancy, etc
    5. General:
    • Unilateral or bilateral above knee lower extremity amputation
    • Inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures
    • Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
    • Pregnancy or breast-feeding or any plan to become pregnant during the study. Women with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible, both partners should use adequate barrier birth control).
    • Previous participation in this study or any other study of rivaroxaban
    • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as a composite endpoint of the following components:
    • Asymptomatic proximal lower extremity DVT detected by mandatory bilateral lower extremity venous ultrasonography at Day 35 +/- 4 days
    • Symptomatic lower extremity DVT (proximal or distal) up to Day 35 + 4 days
    • Symptomatic non fatal PE up to Day 35 + 4 days
    • VTE related death up to Day 35 + 4 days

    The analysis of the primary efficacy endpoint will be solely based on the assessments made by the UAC and the CEAC.

    The major secondary endpoint is defined as the composite of the primary efficacy endpoint (as above), with the addition of all-cause mortality, up to Day 35 + 4 days.

    Further secondary endpoints are given by:
    • Incidence of symptomatic VTE (DVT or PE) up to Day 35 + 4 days
    • Incidence of each of the components of the primary efficacy endpoint
    • Incidence of symptomatic VTE up to Day 90 + 7 days
    • Incidence of all-cause mortality up to Day 90 + 7 days
    • Incidence of the composite of cardiovascular death, acute myocardial infarction or acute ischemic stroke up to Day 35 + 4 days
    • Incidence of the composite of cardiovascular death, acute myocardial infarction or acute ischemic stroke up to Day 90 + 7 days.
    • ‘Net clinical benefit’ as assessed by the composite endpoint comprising the primary efficacy endpoint and treatment-emergent major bleeding or non-major clinically relevant bleeding

    The analysis of the secondary efficacy endpoint will be solely based on the assessments made by the UAC and the CEAC.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA225
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who have experienced Heart failure, NYHA class III or IV and patients who have had an acute ischemic stroke may not be able to provide consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 8000
    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 Decision2008-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 02:54:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA