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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2005-005292-15
    Sponsor's Protocol Code Number:H7T-MC-TABR & TABR (1)
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-005292-15
    A.3Full title of the trial
    A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel (LY640315) versus Clopidogrel in Subjects with Stable Atherosclerosis
    A.3.2Name or abbreviated title of the trial where available
    TABR
    A.4.1Sponsor's protocol code numberH7T-MC-TABR & TABR (1)
    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 SponsorEli Lilly and Company 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 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 namePrasugrel
    D.3.2Product code CS-747, LY640315
    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 INNprasugrel
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeCS-747 hydrochloride salt, LY640315
    D.3.9.3Other descriptive nameLY640315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 60
    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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namePlavix
    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 INNclopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.3Other descriptive nameClopidogrel hydrogen sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 600
    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.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 placeboFilm-coated tablet
    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
    Stable atherosclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level HLT
    E.1.2Classification code 10011085
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the pharmacodynamic effect of a prasugrel 60 mg Loading Dose with a clopidogrel 600 mg Loading Dose, as assessed by change in mean maximal platelet aggregation to 20 mM ADP at 2 hours after LD administration, in aspirin-treated subjects with stable atherosclerosis.
    E.2.2Secondary objectives of the trial
    •Assess pharmacodynamic effects of prasugrel after 60mg LD+aspirin vs clopidogrel 600mg LD+aspirin
    •Assess pharmacodynamics effects of 10mg daily MD prasugrel+aspirin vs 75mg daily MD clopidogrel+aspirin
    •Compare rate of nonresponders for prasugrel vs clopidogrel
    •Compare pharmacokinetic profile of active metabolites for LD and daily MD prasugrel and clopidogrel
    •Assess safety/tolerability for prasugrel vs clopidogrel when co-administered with aspirin in subjects with stable atherosclerosis
    •Assess vasodilator-associated stimulated of platelet activation and other flow cytometric biomarkers of platelet activation of prasugrel vs clopidogrel co-administered with aspirin
    •Assess levels ADP-induced IPA using light transmission aggregometry compared with a point-of-care monitoring device for IPA
    •Assess if variable IPA observed with clopidogrel reflects P2Y12 ADP receptor heterogeneity by the active metabolite of clopidogrel
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Male or female subjects with a history of stable coronary artery disease in whom co-administration of aspirin and a thienopyridine (i.e., clopidogrel or ticlopidine) is not contraindicated.
    Coronary artery disease is defined as any of the following: Subjects diagnosed with chronic stable angina; prior history of unstable angina (including non-ST-segment elevation myocardial infarction) or acute myocardial infarction (AMI); previous coronary revascularization including percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG); or CAD in at least one coronary vessel on previous angiography or noninvasive imaging procedure.
    2.Subjects between the ages of 40 and 75 years (inclusive) with a competent mental condition to provide written informed consent before entering the study. Subjects must provide written informed consent approved by Eli Lilly and Company and the Ethical Review Board governing each site.
    3.Women who are not of child-bearing potential; in other words, either post-menopausal and/or surgical sterilization (including tubal ligation). Post menopausal females are defined as at least 2 years post cessation of menses.
    E.4Principal exclusion criteria
    Cardiovascular Exclusion Criteria
    1.Subjects with unstable coronary artery disease, defined as any of the following observed at screening: new, increased, or rest angina; hospitalization for unstable angina within the previous 30 days; diagnosis of MI within previous 30 days; PCI within previous 90 days; or CABG within previous 90 days.
    2.Subjects with a history of refractory ventricular arrhythmias.
    3.Subjects with a history of an implantable defibrillator device.
    4.Subjects with a history or evidence of congestive heart failure (NYHA Class III or above) within 6 months prior to screening.
    5.Subjects with significant hypertension (systolic blood pressure >180 or diastolic blood pressure >110 mmHg) at the time of screening or randomization.
    6.Any coronary revascularization (surgical or percutaneous) performed within 3 months prior to randomization.
    7.Any coronary revascularization (surgical or percutaneous) planned within 40 days following randomization.
    Bleeding Risk Exclusion Criteria
    8.Any known contraindication to treatment with an anticoagulant or antiplatelet agent.
    9.Prior history or presence of significant bleeding disorders (for example, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding).
    10.Prior history or clinical suspicion of cerebral vascular malformations, for example, prior history of cerebral hemorrhage, aneurysm or premature stroke (CVA <65 years of age).
    11.Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).
    12.Personal or family history of coagulation or bleeding disorders.
    13.Prior history of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (platelet count > 500,000/mm3).
    14.Clinically significant out of range values for PT, aPTT, platelet count or hemoglobin at screening, in the investigator’s opinion.
    15.History of major surgery, severe trauma, fracture or organ biopsy within 3 months prior to enrollment.
    16.Any planned surgical procedure within 40 days following randomization.
    Prior/Concomitant Therapy Exclusion Criteria
    17.Subjects taking ticlopidine or clopidogrel less than or equal 10 days prior to screening.
    18.The use (or planned use) of antiplatelet agents (besides aspirin), heparin, warfarin or fibrinolytic agents within 30 days of screening.
    19.Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
    General Exclusion Criteria
    20.Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
    21.Results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator.
    22.Subjects who are unreliable and unwilling to make themselves available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions.
    23.Subjects enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
    24.Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel, prasugrel or ticlopidine).
    25.Evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator’s opinion.
    26.Blood donation of more than 500 mL within the previous 3 months.
    27.Evidence of active hepatic disease, or any of the following; positive human immunodeficiency virus (HIV) antibodies, positive hepatitis C antibody, positive hepatitis B surface antigen.
    28.Lilly or Sankyo employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the mean change from baseline (pre-LD) in MPA to 20 µM ADP at 2 hours post-LD .
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2006-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-06
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