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    Summary
    EudraCT Number:2010-022134-89
    Sponsor's Protocol Code Number:CL3-06790-010
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-15
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2010-022134-89
    A.3Full title of the trial
    The efficAcy and safety of Trimetazidine in Patients with
    angina pectoris having been treated by percutaneous Coronary
    Intervention.
    ATPCI study
    An international, multicentre, randomised, double-blind, placebo-controlled study in patients treated for 2 to 4 years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of trimetazidine in patients with angina having been treated by dilatation of coronary arteries.
    A.4.1Sponsor's protocol code numberCL3-06790-010
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1145-1743
    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 SponsorI.R.I.S.
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 rue Carnot
    B.5.3.2Town/ citySuresnes
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number01.55.72.43.66
    B.5.5Fax number01.55.72.54.12
    B.5.6E-mailhelene.rault@fr.netgrs.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 Yes
    D.2.1.1.1Trade name VASTAREL MR 35mg
    D.2.1.1.2Name of the Marketing Authorisation holderLES LABORATOIRES SERVIER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameS06790
    D.3.2Product code S06790
    D.3.4Pharmaceutical form Modified-release 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 INNTRIMETAZIDINE DIHYDROCHLORIDE
    D.3.9.1CAS number 13171-25-0
    D.3.9.2Current sponsor codeS06790
    D.3.9.3Other descriptive nameTRIMETAZIDINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB12374MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Angina pectoris having been treated by Percutaneous Coronary Intervention
    E.1.1.1Medical condition in easily understood language
    Patients with angina having been treated by dilatation of coronary arteries.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10002383
    E.1.2Term Angina pectoris
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the superiority of trimetazidine over placebo in preventin recurrence or exacerbation of angina pectoris and reducing cardiac events, and to document its safety by analysing the occurrence of serious adverse events
    E.2.2Secondary objectives of the trial
    Evaluate the effect of trimetazidine on the other efficacy endpoints as well as the other safety parameters, clinical and biological
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women or men ≥ 21 years old and < 85 years old of any ethnic origin
    Patients presenting a single or multivessel coronary artery disease and having undergone PCI treating at least one stenosis to either a native coronary artery or a coronary graft where the PCI was:
    - indicated because of angina pectoris occurring either in the context of stable angina (elective PCI) or in the context of an acute presentation such as unstable angina/NSTEMI, but excluding STEMI,
    - achieved by stent implantation or by other acceptable interventional means,
    - successful as planned by the operator and with no further revascularization (either percutaneous or surgical) planned,
    - uncomplicated such that the patient's discharge was not, or will not be, delayed because of a cardiac or cerebrovascular problem
    E.4Principal exclusion criteria
    - Severe uncontrolled rythm disturbances including paroxysmal VT and SVT
    - Kown severe aortic or mitral valve disease
    - Clinical signs and/or symptoms of heart failure corresponding to NYHA class IV
    - Hypertrophic obstructive cardiomyopathy or other forms of left ventricular outflow tract obstruction
    - Active myocarditis, pericarditis or endocarditis
    - Hystory of agranulocytosis, severe thrombocytopenia or severe coagulation disorder
    - History of pulmonary embolism within preceding 6 months
    - Known severe uncontrolled arterial hypertension
    - Known chronic severe or moderate renal failure, with sCrCl < 60 mL/min or eGFR<60 mL/min/1.73m2
    - Current or previous movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremor, gait instability of central origin
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of an event in the composite of:
    - Cardiac death
    - Hospitalisation for a cardiac event
    - Recurrent or persistent angina leading to adding, switching or increasing the dose of one of the evidence-based antianginal therapies
    - Recurrent or persistent angina leading to performing a coronary angiography
    E.5.1.1Timepoint(s) of evaluation of this end point
    all over the study
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints and safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    All over the study
    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 No
    E.6.7Pharmacodynamic No
    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) 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 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.8.2.4Number of treatment arms in the trial3
    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 EEA305
    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
    Serbia
    Algeria
    Armenia
    Austria
    Belarus
    Brazil
    Bulgaria
    Chile
    China
    Colombia
    Croatia
    Denmark
    Estonia
    France
    Georgia
    Germany
    Greece
    Hungary
    Indonesia
    Italy
    Jordan
    Kazakhstan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Montenegro
    Morocco
    Netherlands
    Portugal
    Spain
    Thailand
    Macedonia, the former Yugoslav Republic of
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    Slovenia
    South Africa
    Switzerland
    Tunisia
    Turkey
    Ukraine
    Vietnam
    Argentina
    Bosnia and Herzegovina
    Canada
    Czech Republic
    Egypt
    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 Visit Last Participant as stated in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 5900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4400
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4330
    F.4.2.2In the whole clinical trial 10300
    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)
    After discontinuation of the IMP, the participant will receive appropriate treatment and/or have access to other appropriate care by his doctor
    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 Decision2013-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-13
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