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    Summary
    EudraCT Number:2005-006029-94
    Sponsor's Protocol Code Number:E5555-G000-201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-006029-94
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease
    A.3.2Name or abbreviated title of the trial where available
    E5555-G000-201
    A.4.1Sponsor's protocol code numberE5555-G000-201
    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 SponsorEisai Limited
    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 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.3.2Product code E5555
    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.3.9.1CAS number 474550-69-1
    D.3.9.2Current sponsor codeE5555
    D.3.9.3Other descriptive nameTRIC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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.3.2Product code E5555
    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.3.9.1CAS number 474550-69-1
    D.3.9.2Current sponsor codeE5555
    D.3.9.3Other descriptive nameTRIC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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
    Coronary Artery Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of E5555 in patients with coronary artery disease.
    E.2.2Secondary objectives of the trial
    To determine the effect of E5555 on (a) the incidence of major adverse cardiovascular effects (MACE) (cardiovascular death, myocardial infarction, stroke and refractory ischemia) and b) platelet aggregation inhibition (in qualified sites in subjects willing to take part in this component of the study). The exploratory objective being pursued is to determine the effect of E5555 on the endovascular inflammatory processes that are believed to be integral to the pathogenesis of coronary artery disease. In addition, the pharmacokinetics of E5555 and its metabolites will be determined. Qualified sites will conduct comprehensive plasma sample collection for measurement of levels of E5555 and its metabolites to evaluate the relationship between E5555 pharmacokinetics and pharmacodynamics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 45 – 80 years, inclusive
    • Males or Females (women of child-bearing potential must use adequate protection)
    • Confirmed coronary artery disease defined as one of the following:
    - Post-ACS or MI or Post PCI (greater than 4 weeks) or
    - CABG (greater than 12 weeks) or
    - Angina pectoris with documented (ECG or imaging study) ischemia or
    - Angiographically documented lesion occluding ≥70% of a coronary vessel
    And at high risk as defined by one or more of the following:
    • Screening hsCRP ≥ 3.0 mg/L
    • History of diabetes mellitus under Rx treatment
    • Documented history of peripheral arterial disease
    • Documented history of Thrombo-embolic TIA or stroke greater than 1 year prior to screening
    • Documented history of Carotid artery disease
    All subjects must be receiving low-dose (75-325 mg) aspirin and or clopidogrel 75 mg once daily. Ticlopidine 250mg twice daily with or without low dose aspirin once daily is also allowed. These medications must be taken for at least 1 month prior to screening.
    E.4Principal exclusion criteria
    • Unwilling or unable to provide informed consent
    •History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
    • Recent trauma or major surgery in the past 30 days prior to Screening
    • Evidence of active pathological bleeding at screening or history of bleeding (such as gastrointestinal or genitourinary) within the 6 months prior to Screening, unless the cause has been definitely corrected
    • History of intracranial bleeding (eg, hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy
    • History of ischemic stroke or transient ischemic attack within the past year prior to Screening or known structural cerebral vascular lesion (eg, arterial venous malformation, aneurysm)
    • Hematological abnormalities: INR >1.5 or PTT >1.5 X ULN, Platelet count
    <100 x (10)3/µL (<100 x (10)9/L), Hemoglobin <10 g/dL at Screening
    • History of New York Heart Association class 3 or 4 congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at Screening
    • Significant (as determined by the Investigator) cardiovascular events in the 30 days prior to the Screening Visit or newly prescribed or dose adjustments made to cardiovascular medications in the 30 days prior to the Screening Visit
    • Planned elective surgical operation or major invasive procedure from 30 days before screening to completion of the study (The decision of what constitutes a major invasive procedure will be at the discretion of the investigator in conjunction with review and approval by the medical monitor)
    • Unstable diabetes requiring frequent adjustments to medications (other than insulin) in the 30 days prior to the Baseline Visit
    • Documented history of chronic liver disease and/or Screening ALT or AST >3 x ULN or Total Bilirubin >1.5 x ULN (unless the abnormal bilirubin level is secondary to Gilbert’s syndrome)
    • Documented presence of rheumatologic or autoimmune diseases requiring continuous treatment with anti-inflammatory agents
    • Significant renal impairment, defined as creatinine clearance <30 mL/min
    • History of cancer (other than basal cell carcinoma of the skin, cervical carcinoma in situ, or low-grade prostate cancer), unless adequately treated with no evidence of disease recurrence for at least 2 years
    • Recent (within 14 days prior to Baseline Visit) significant infection or history of chronic infections with a recurrence <14 days prior to the Screening Visit and/or requiring continuous antibiotic treatment
    • Use of any of the following drugs in the 30 days prior to Screening and for the duration of the study:
    - Oral anti-thrombotics other than low dose aspirin (daily aspirin dose of 325 mg
    or lower) and/or clopidogrel (75 mg) and/or ticlopidine (250 mg bid)
    - Anticoagulants (eg, coumadin, warfarin)
    - Fibrinolytics (eg, TPA, streptokinase, urokinase)
    - NSAIDs, other than occasional use
    - COX-2 inhibitors, other than occasional use
    - Potent and moderate CYP (global) 3A4 inhibitors
    - Selected CYP 2D6 substrates
    - Herbals with antiplatelet properties: Gingko biloba, Horse chestnut
    (Aesculus hippocastanum)
    • Use of another investigational drug within 30 days prior to the Screening Visit or use of an investigational device (eg, unapproved stent) within 12 weeks prior to the Screening Visit
    • Pregnant, or nursing women.
    • use of illicit drugs or alcohol abuse 3 months prior to the screening or during the course of the study.
    • A marked prolongation of QT/QTc interval (<500 msec over baseline) at the Screening (Day -21 to -1) or Baseline visits (Day 1).

    E.5 End points
    E.5.1Primary end point(s)
    The primary goal of this study is to assess the effect of E5555 on general safety and
    tolerability in high risk patients with coronary artery disease especially the risk of bleeding. The primary outcome will be the proportions of subjects with CEC-adjudicated bleeds. Cross-classification tables of CEC-adjudicated major bleeds vs treatment groups will be created. Safety and tolerability will be determined by comparison of SAEs, treatment emergent AE, treatment emergent abnormal laboratory values, and ECG changes in the three treatment groups with those in the placebo group.
    The secondary endpoint used to assess efficacy issues between the treatment groups will be the proportion of subjects with CEC-adjudicated MACE events.
    Exploratory parameters: To determine possible anti-inflammatory effects of E5555, the inflammatory marker hsCRP will be measured at Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28. Summary estimates of other biomarkers may be created to explore the efficacy differences between the treatment groups. ANOVA or ANCOVA (if necessary to adjust for Baseline) models will be used to compare the continuous biomarkers and Fischer's exact test will be used to compare the exact proportions of subject differences in the categorical biomarkers. A regression model will be created for the platelet aggregation and demographic and inflammatory biomarkers as covariates. A Bayesian model under various prior distribution assumptions may also be employed to better understand the bleeding episode profile.
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 720
    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 Decision2007-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
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