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    Summary
    EudraCT Number:2006-000296-15
    Sponsor's Protocol Code Number:E555-G000-202
    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:2007-10-23
    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 number2006-000296-15
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome
    A.4.1Sponsor's protocol code numberE555-G000-202
    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 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.3.9.2Current 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 Information not present in EudraCT
    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 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.3.9.2Current 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 Information not present in EudraCT
    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
    D.8 Placebo: 2
    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
    Coronary Artery Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    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 objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of ACS. This will be assessed for a period of up to 16 weeks (112 days).
    E.2.2Secondary objectives of the trial
    •To determine the effect of E5555 on major adverse cardiac events (MACE), which include cardiovascular death, myocardial infarction [MI], stroke or refractory ischemia
    •To provide data that can be used to help determine the safe and effective clinical dose range
    •To determine the effect of E5555 on the incidence of transient ischemia ( a predictor of MACE) assessed by continuous (holter) ECG monitoring for the initial 48 hours following randomisation
    •To describe the pharmacokinetics (PK) of E5555 and its metabolites in the patient population using an appropriate parametric PK model, and to obtain an evaluable dataset of individual patient exposures for exploration of exposure-response relationships with safety, efficacy and pharmacodynamic (PD) outcomes
    •Additional exploratory analyses aim to identify significant patient specific covaraites with PK variables and determine the relationships between E5555 PK exposure and PD parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Men and women (women of child-bearing potential must use adequate contraception)
    •Presenting with features of non-ST segment elevation ACS (unstable angina or MI without persistent ST elevation). There must be new onset or a worsening pattern of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerin for relief of the pain)
    •Randomisation and treatment possible within 72 hours of the onset of symptoms. Every effort should be made to randomise and treat eligible subjects as soon after hospital admission as possible.
    •Age 18–80 years inclusive and at least one of the following two criteria on admission:
    - Troponin T or I ≥ ULN or CKMB ≥ ULN for the local institution
    - ECG changes compatible with ischemia (i.e. ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation)
    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 (within the 30 days prior to screening/baseline)
    •Recent (within 14 days prior to screening/baseline) significant infection or history of chronic infections with a recurrence < 14 days prior to screening/baseline visit and/or requiring continuous antibiotic treatment
    •Evidence of active pathological bleeding at screening/baseline or history of bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening/baseline visit, unless the cause has been definitely corrected
    •History of intracranial bleeding e.g. 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/baseline or known structural cerebral vascular lesion (eg, arteriovenous malformation [AVM], aneurysm)
    •Haematological abnormalities: platelet count <100 x 103 / μL, haemoglobin < 10 g/dL at screening/baseline visit (day 1)
    •History of NYHA class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening/baseline
    •Patients with ST-segment changes at baseline attributed to left ventricular hypertrophy with repolarisation changes, bundle branch block and digoxin will be excluded.
    •Percutaneous cardiac intervention or coronary artery surgery in the previous 12 weeks prior to the screening/baseline visit
    •Significant (as determined by the investigator) cardiovascular events (such as a Q wave MI) within the past 30 days prior to the screening/baseline visit
    •Planned elective surgical operation or major invasive procedures planned from 30 days prior to 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 screening/baseline visit
    •Documented history of chronic liver disease and/or screening/baseline ALT or AST > 3 x ULN or total bilirubin > 1.5 x ULN (unless the abnormal bilirubin is secondary to Gilbert’s syndrome)
    •History of rheumatologic or autoimmune diseases
    •Significant renal impairment, defined as creatinine clearance of < 30mL/min
    •History of cancer (other than basal cell carcinoma, cervical carcinoma in situ, or low-grade prostate cancer), unless adequately treated with no evidence of disease recurrence for at least 2 years
    •Use of any of the following drugs in the 30 days prior to the screening / baseline visit and for the duration of the study:
    - Oral platelets other than aspirin (daily aspirin dose of 325 mg or lower) and/or clopidogrel (75 mg chronically; loading dose allowed) and/or Ticlopidine (250mg BID)
    - Oral anticoagulants (e.g. acecoumarol, warfarin)
    - Fibrinolytics (eg, tPA, streptokinase, urokinase)
    - NSAIDs (including COX-2 inhibitors) other than occasional use
    - Potent and moderate CYP (global) 3A4 inhibitors
    - Selected CYP 2D6 subtrates
    - Herbals with anti-platelet properties:Gingko biloba, horse chestnut (Aesculus hippocastanum)
    •Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, eg, unapproved stents) prior to sceening/baseline visit
    •Pregnancy or nursing women
    •Use of ilicit drugs or alcohol abuse 3 months prior to screening or during the course of the study
    •A marked prolongation of QT/QTc interval (>500 ms) at the Screening/Baseline vist (Day 1)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be proportions of patients with CEC-adjudicated major bleeds. Cross-classification tables of CEC-adjudicated major bleeds versus treatment group will be created.

    Safety and tolerability will be determined by comparison of incidences of treatment-emergent SAEs, treatment-emergent AEs, treatment-emergent abnormal lab values and changes in ECGs in the safety population.

    Two main secondary endpoints will be used to assess efficacy issues between the treatment groups. The first will be the proportion of patients with CEC-adjudicated MACEs.The second efficacy endpoint will be the proportion of subjects with 24-h Holter-detected ischemia as defined by a ST-segment shift ≥ 0.1 mV below/above the baseline, ≥ 1 minute in duration, and separated from other episodes of ST segment shift by ≥ 1 minute.
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Last Patient Last Visit
    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 months5
    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 months5
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 600
    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)
    The patients in this study are followed-up for 4 weeks after stopping study drug at Week 12. They will have been taking ‘standard’ antiplatelet therapy with oral aspirin and clopidogrel (or ticlopidine) throughout the first 12 weeks of the study and will continue on this antiplatelet treatment for the next 4 weeks to the end of the study (and beyond). Safety asseesments will be done at Week 16, or 4 weeks after stopping study drug if that as happened before Week 12.
    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 Decision2007-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-09
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