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    Summary
    EudraCT Number:2010-023184-18
    Sponsor's Protocol Code Number:C10-44
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-023184-18
    A.3Full title of the trial
    PRE clinical mutation CARriers from families with DIlated cardiomyopathy and ACE inhibitors (PRECARDIA-INHERITANCE study)

    Preventive effect of ACE inhibitor (perindopril) on the onset or progression of left ventricular dysfunction in subjects at a preclinical stage from families with dilated cardiomyopathy
    A.3.2Name or abbreviated title of the trial where available
    PRECARDIA study
    A.4.1Sponsor's protocol code numberC10-44
    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 SponsorInserm
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationINSERM
    B.5.2Functional name of contact pointAnne PUECH
    B.5.3 Address:
    B.5.3.1Street AddressInstitut Santé Publique - 101 rue de Tolbiac
    B.5.3.2Town/ cityParis Cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number01.44.23.60.47
    B.5.5Fax number01.44.23.67.10
    B.5.6E-mailrqrc.siege@inserm.fr
    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 Coversyl 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Servier - Neuilly sur seine - France
    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.3.4Pharmaceutical 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 INNperidopril arginine
    D.3.10 Strength
    D.3.10.3Concentration number5 mg
    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
    dilated cardiomyopathy
    E.1.1.1Medical condition in easily understood language
    Patients carrying a mutation responsible for dilated cardiomyopathy and who are at a preclinical stage of the disease.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10056419
    E.1.2Term Dilated cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM through a double blind randomized (parallel group) multicenter trial.
    - to extend the medical impact of predictive genetic testing in DCM (direct therapeutic impact).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - adults: 18-60 years
    - carriers of the mutation has been identified in the family as associated with DCM and who have received appropriate genetic counselling before and after the announcement of the genetic result
    - at least one family member should have a clinical diagnosis of dilated cardiomyopathy
    - no obvious DCM assessed
    - presence of minor LV abnormality: isolated LVEDD >112% or reduced systolic dysfunction : LVEF <55%, as assessed on echocardiography
    - able to provide informed consent and signed consent.
    E.4Principal exclusion criteria
    * Subject < 18 years old or > 60 years
    * Other disease or factor that can cause minor LV abnormalities, such as cardiotoxic treatment or significant blood hypertension (with uncontrolled blood pressure or significant hypertrophy on echocardiography).
    * Contraindication to ACE inhibitor (prior intolerance or adverse reaction, e.g. angio-oedeme, patients with hereditary or idiopathic angioedema, hypersensitivity to perindopril or any of the excipients (e.g. hereditary problems of galactose intolerance, glucose galactose malabsorption, or the Lapp lactase deficiency))
    * Impaired renal function (serum creatinine > 150 micromol/l).
    * Baseline serum potassium >5.5 mmol/L.
    * Pregnant, parturient or breastfeeding woman or woman of childbearing potential not under effective contraception or planned pregnancy.
    * Participation in another therapeutic trial in the previous 3 months
    * Participants who are already treated with ACE inhibitor or sartan or aldosterone receptor antagonists (for various reason such as arterial hypertension) can not be included in this study, unless they have been off these drugs for a period of 6 weeks before inclusion.
    * Participants treated with lithium
    * participant under legal guardianship
    E.5 End points
    E.5.1Primary end point(s)
    occurence of DCM or deterioration of LV end-diastolic diameter / volume or deterioration of Ejection fraction; all criteria determined either by Echocardiography or by magnetic resonance imaging (MRI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Echocardiography: 1, 2, 3 years
    magnetic resonance imaging (MRI): 3 years
    E.5.2Secondary end point(s)
    - echocardiographic deterioration of LVEDD or ejection fraction
    - MRI deterioration of LVEDVol or Ejection fraction
    - occurence of DCM
    - Deterioration of other Echocardiographic parameters:
    TDI velocities (average Sa & Ea velocities) at the mitral annulus (lateral and septal), and the E/Ea ratio
    TDI strain and strain rate (radial, longitudinal, circonferential strain rate in the basal, mid and apical segments)
    LV volumes (LVED Vol and LVES Vol, Simpson method, 4 cavity incidence)
    - Deterioration of hormonal biomarkers in serum:
    Natriuretic peptid: BNP and NTproBNP (+/-4% or final versus baseline).
    Mid-Regional pro-Adrenomedullin (MR-proADM) and Mid-Regional proANP, (+/-4% or final versus baseline)
    - other planned end-point but without sufficient statistical power: symptoms (dyspnoea: NYHA stage 1 to 4); hospitalisation (not planned) for heart failure); Safety end-point: nos excess of all cause death, cardiovascular death

    E.5.2.1Timepoint(s) of evaluation of this end point
    biological analysis: last visit

    Echocardiography: 1, 2, 3 years
    magnetic resonance imaging (MRI): 3 years
    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 No
    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 trial2
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 No
    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 years6
    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 years6
    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: 200
    F.1.3Elderly (>=65 years) No
    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 No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    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)
    The treatment will be discontinued after 3 years of treatment and the participant's treatment assignement will remain blinded.

    The investigators will be free for recommending the prescription of perindopril (or another ACEi) or not after the end of the study.


    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 Decision2011-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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