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    Summary
    EudraCT Number:2012-003009-88
    Sponsor's Protocol Code Number:DU176b-E-U210
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003009-88
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP,
    MULTI-CENTER STUDY OF ADDING EDOXABAN OR
    CLOPIDOGREL TO ASPIRIN TO MAINTAIN PATENCY
    IN SUBJECTS WITH PERIPHERAL ARTERIAL DISEASE
    FOLLOWING FEMOROPOPLITEAL ENDOVASCULAR
    INTERVENTION-edoxaban in Peripheral Arterial Disease
    (ePAD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of new oral anticoagulant (Edoxaban) plus aspirin versus oral antiplatelet (clopidogrel) plus aspirin in PAD patients who have had their vessels opened by intervention to preserve the opened vessel and prevent reocclusion of the treated vessel.
    A.3.2Name or abbreviated title of the trial where available
    edoxaban in Peripheral Arterial Disease (ePAD)
    A.4.1Sponsor's protocol code numberDU176b-E-U210
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Sankyo Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportDaiichi Sankyo Pharma Development Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441753482800
    B.5.5Fax number+441753899107
    B.5.6E-mailinfo@dsd-eu.com
    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 nameEdoxaban tosylate
    D.3.2Product code DU-176b
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.2Current sponsor codeDU-176b
    D.3.9.3Other descriptive nameEDOXABAN
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 Yes
    D.2.1.1.1Trade name Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNClopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.3Other descriptive nameCLOPIDOGREL BISULFATE
    D.3.9.4EV Substance CodeSUB12483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Edoxaban is being investigated for use in PAD subjects after femoropopliteal endovascular interventions with/without stent placement for the maintenance of patency and prevention of re-intervention.
    E.1.1.1Medical condition in easily understood language
    Circulatory problem in which narrowed arteries reduce blood flow to the limbs causing pain and requiring intervention to open the vessels and allow blood flow and consequently relieving pain.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10067825
    E.1.2Term Peripheral arterial disease
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate clinically relevant bleeding (i.e., major or clinically relevant nonmajor bleeding) occurring during treatment or within 3 days of interrupting or stopping study drug.
    - To evaluate re-stenosis/re-occlusion [defined as peak systolic velocity (PSV) ratio >/= 2.4] at the treated segment(s) measured at 1, 3 and 6 months after randomization using color coded duplex ultrasonography scanning (DUS).
    E.2.2Secondary objectives of the trial
    -To evaluate any bleeding (major, clinically relevant non-major, and minor bleeding) occurring during treatment or within 3 days of interrupting or stopping study drug.
    - To evaluate all other clinical and laboratory safety assessments including adverse events (AEs), serious adverse
    events (SAEs), and other events of special interest (i.e., hepatic events).
    - To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban in PAD subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects older than the minimum legal adult age (country specific);
    2. Rutherford stages 2-5 provided there are no ulcerations on the heel
    and/or exposed tendon and/or bone;
    3. Superficial femoral, above-knee popliteal (3 cm proximal to the medial
    femoral condyle) lesion and ≥ 50% stenosis or occlusion;
    4. At least one run-off vessel to the foot with or without additional endovascular intervention;
    5. Successful intervention, defined as angiographic confirmation of ≤ 30% residual stenosis and absence of flow limiting dissection;
    6. Adequate hemostasis at the vascular access site within 24 hours of intervention;
    7. A subject is eligible if they have undergone additional successful
    endovascular intervention(s) during the index intervention;
    8. Able to provide signed informed consent.
    E.4Principal exclusion criteria
    1. Calculated CrCL < 30 ml/min;
    2. Femoral or popliteal aneurysm;
    3. Adjunctive use of thrombolytics;
    4. Any extravasation or distal embolization not successfully treated;
    5. Uncontrolled hypertension as judged by the investigator (e.g., systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg
    despite antihypertensives);
    6. Aspirin intolerance;
    7. Clopidogrel intolerance;
    8. Contraindication for anticoagulants or antiplatelets and any other contraindication listed in the local labeling of aspirin and/or clopidogrel
    (see Appendix 17.8 for US and EU labeling);
    9. Active bleeding or known high risk for bleeding or history of intracranial, or spontaneous intraocular, spinal retroperitoneal or intra-articular bleeding; overt gastrointestinal (GI) bleeding or active ulcer within the previous year;
    10. Subjects receiving dual antiplatelet or anticoagulant therapy at the time of randomization; subjects receiving pre-interventional loading dose of clopidogrel or other P2Y12 receptor antagonists; see Appendix 17.5. for details;
    11. Treatment with cilostazol within 24 hours of randomization;
    12. Subjects receiving prohibited concomitant medications [fibrinolytics,
    chronic use of non steroidal anti-inflammatory drugs (NSAIDS) > 4 days per week, and oral or parenteral non-aspirin NSAIDs and strong P-gp inhibitors]; see Appendix 17.5 for list of prohibited concomitant medications;
    13. Prior stroke or MI or acute coronary syndrome within 3 months;
    14. Chronic liver disease [alanine transaminase (ALT) and/or aspartate
    transaminase (AST) ≥ 2 × upper limit of normal; total bilirubin (TBL) ≥
    1.5 × upper limit of normal]; however, subjects whose elevated TBL is
    due to known Gilbert's syndrome may be included in the study;
    15. Prior history of a positive test for Hepatitis B antigen or Hepatitis C antibody;
    16. Subjects who received any investigational drug or device within 30 days prior to randomization, or plan to receive such investigational therapy during the study period;
    17. Subjects previously randomized to an edoxaban (DU-176b) study;
    18. Women of childbearing potential without proper contraceptive measures (i.e. a method of contraception with a failure rate < 1 % during the course of the study including the observational period) and women who are pregnant or breast feeding;
    Note: These methods of contraception according to the note for guidance on nonclinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence, and vasectomy for the male partner;
    19. Subjects with the following diagnoses or situations:
    - Active malignancy except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g., cervical cancer in situ);
    - Concurrent treatment with cancer therapy (drugs, radiation, and/or surgery);
    - Other significant active concurrent medical illness or infection;
    - Life expectancy < 12 months;
    20. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, and/or otherwise considered by the Investigator to be unlikely to complete the study);
    21. Subjects with any condition that, in the opinion of the Investigator, would place the subject at increased risk of harm if he/she participated in the study;
    22. History of heparin-induced thrombocytopenia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint:
    The primary safety endpoint is clinically relevant bleeding (i.e., major or clinically relevant non major bleeding) occurring during treatment or within 3 days of interrupting or stopping study drug.
    Primary Efficacy Endpoint:
    The primary efficacy endpoint is re-stenosis/reocclusion
    (as defined by PSV ratio >= 2.4) at the treated segment(s) measured at 1, 3 and 6 months, using color-coded DUS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Safety Endpoint:
    During treatment or within 3 days of interrupting or stopping study drug.
    Primary Efficacy Endpoint:
    measured at 1, 3 and 6 months.
    E.5.2Secondary end point(s)
    · Change in PSV ratio in the treated segment(s) at 3 and 6 months compared to 1 month;
    · Change from baseline ABI at 3 and 6 months;
    · Rutherford stage at 1, 3 and 6 months;
    · Symptomatic acute thrombosis;
    · Target lesion revascularization (percutaneous or surgical);
    · MACE;
    · SEE (fatal and non-fatal)
    · All cause mortality;
    · Amputations;
    · PK: Plasma concentrations of edoxaban and its metabolite (D21-2393) on Days 30 and 90;
    · Pharmacodynamics (PD): Plasma concentrations of PD biomarkers on Days 30 and 90 (anti-FXa activity, intrinsic FX, aPTT, PT/INR, D-dimer, sP-selectin, CRP and TGA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSV ratio - 3 and 6 months and 1 month - used as comparison
    Change from baseline ABI - 1, 3 and 6 months
    Rutherford stage - screening, 1, 3 and 6 months
    PK – Days 30 and 90
    PD – Days 30 and 90
    All other secondary endpoints – throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Switzerland
    United States
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    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 Decision2012-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-03
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