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    Summary
    EudraCT Number:2015-002060-17
    Sponsor's Protocol Code Number:2015/077/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-05
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002060-17
    A.3Full title of the trial
    Effect of pharmacological heart rate reduction on visco-elastic properties of the arterial wall - Impact of aging
    Effet de la réduction pharmacologique de la fréquence cardiaque (FC) sur les propriétés viscoélastiques de la paroi artérielle – impact du vieillissement
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of heart rate reduction on the arterial wall - Impact of aging
    Effet de la réduction de la fréquence cardiaque sur la paroi artérielle – impact du vieillissement
    A.3.2Name or abbreviated title of the trial where available
    BRADY-VASC
    BRADY-VASC
    A.4.1Sponsor's protocol code number2015/077/HP
    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 SponsorCHU - Hôpitaux de Rouen
    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 supportCHU - Hôpitaux de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDélégation à la recherche clinique et à l'innovation
    B.5.2Functional name of contact pointMEYOHAS
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen cedex
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.5Fax number+33232888265
    B.5.6E-mailsecretariat.DRC@chu-rouen.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 PROCORALAN
    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.3.4Pharmaceutical form Capsule
    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 INNIvabradine
    D.3.9.1CAS number 148849-67-6
    D.3.9.4EV Substance CodeSUB22933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule
    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
    Healthy subjects between 25 and 65 years old
    Volontaires sains, d’âge compris entre 25 et 65 ans
    E.1.1.1Medical condition in easily understood language
    Healthy subjects between 25 and 65 years old
    Volontaires sains, d’âge compris entre 25 et 65 ans
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10007574
    E.1.2Term Cardiac imaging procedures
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10052677
    E.1.2Term Vascular imaging
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10006093
    E.1.2Term Bradycardia
    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
    To assess the effect of heart rate reduction after repeated administration of ivabradine on wall viscosity of the common carotid artery in healthy subjects
    Evaluer l'effet de la bradycardie induite par l’administration répétée d’ivabradine sur la viscosité pariétale de l’artère carotide primitive chez des sujets sains.
    E.2.2Secondary objectives of the trial
    - To assess the effect of heart rate reduction after repeated administration of ivabradine on vascular geometry and function, and cardiovascular haemodynamics in healthy subjects

    - To assess the role of aging on the effect of heart rate reduction after repeated administration of ivabradine on all these parameters in healthy subjects
    - Evaluer l'effet de la bradycardie induite par l’administration répétée d’ivabradine sur la géométrie et la fonction vasculaire et sur l'hémodynamique systémique chez des sujets sains.
    - Evaluer l’influence de l’âge sur l'effet de la bradycardie induite par l’administration répétée d’ivabradine pour l’ensemble des paramètres précédents chez des sujets sains.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Healthy subject
    • Aged between 25 and 65 years old
    • Caucasian
    • Resting heart rate mesured three times after a rest period of 15 min ≥ 70 bpm
    • No significant ECG abnormality
    • No significant biological abnormality
    • Childbearing age women must have effective contraception (estrogen-progestin contraceptives, intrauterin device or tubal ligation). Will be considered postmenopausal women with amenorrhea for more than 2 years
    • Able to read and understand information form and to give written informed consent
    • Subjects with medical insurance
    Sujet sain
    Agé de 25 à 65 ans
    Origine caucasienne
    FC de base ≥ 70 bpm, calculée sur 3 mesures après une période de repos de 15 minutes
    Absence d’anomalie cliniquement significative de l’ECG
    Absence d’anomalie cliniquement significative sur la biologie d’inclusion
    Volontaire sain ayant lu et compris la lettre d’information et signé le formulaire de consentement. Volontaire sain bénéficiant d'un régime d'assurance maladie
    Femmes en âge de procréer ayant une contraception efficace (oestro-progestatifs ou dispositif intra-utérin ou ligature des trompes) depuis 2 mois.
    (NB : Seront considérées comme ménopausées les femmes présentant une aménorrhée depuis plus de 2 ans)
    E.4Principal exclusion criteria
    • Subjects who don’t understand French language

    • Subjects deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)

    • Pregnant women, nursing mother or women without contraception

    • Subjects who participate to an other trial / participated to an other interventional research without drugs during the last month or a trial with drugs during the last 3 months

    • Hypersensitivity to the active substance or to any of the excipients

    • Congenital galactosemia, lactase deficiency (Lapp), malabsorption of glucose and galactose

    • Severe hypotension, mesured three times after a rest period of 15 min (< 90/50 mmHg)

    • Essential or secondary hypertension, mesured three times after a rest period of 15 min (SBP ≥140 mmHg and/or DBP ≥90 mmHg)

    • Smoking at the day of inclusion (>5 cigarettes/day)

    • Severe hypercholesterolemia (Total cholesterol >2,5 g/L)

    • Subjects who practice sports intensively (≥ 1 hour/day)

    • Renal insufficiency (creatinine clearance ≤ 60 ml/min/1,73 m² Cockroft and Gault formula)

    • Known liver failure

    • Known heart failure or suspected heart failure (congestive episode)

    • Atrial fibrillation

    • High-grade conduction block (Sick sinus syndrome, sino-atrial block or grade 2 or 3 atrio-ventricular block)

    • Abnormal corrected QT with Bazett formula (cQT > 450 ms (men) or > 470 ms (women)).

    • Pacemaker

    • All cardiac or no cardiac diseases, active or with sequelae, which, in the opinion of the investigator, is accompanied by a risk of cardiac or vascular abnormality

    • Known retinal disease

    • Subject disagrees with the prohibition of taking grapefruit juice, millepertuis or any medication during the study except oral contraceptive, acetaminophene or decision of the investigator. (annex n°02)

    • Administration of any medication listed in anex n°02 (aspirin, NSAID and inhibitors of cytochrome P450 3A4) during the previous week.
    • Sujets comprenant mal le français parlé ou écrit
    • Personne privée de liberté par une décision administrative ou judiciaire ou sujet majeur protégé (sous tutelle ou curatelle)
    • Femme enceinte ou allaitant ou absence de contraception avérée
    • Volontaire sain participant à un autre essai / ayant participé à une autre recherche interventionnelle dans un délai de 1 mois ou à un essai médicament dans un délai de 3 mois
    • Hypersensibilité connue à la substance active, aux excipients ou au contenant (gélules)
    • Galactosémie congénitale, déficit en lactase (Lapp), ou syndrome de malabsorption du glucose et du galactose
    • Indice de masse corporelle (IMC) < 18 kg/m² ou > 30 kg/m²
    • Hypotension sévère calculée sur 3 mesures après une période de repos de 15 minutes (< 90/50 mmHg)
    • Hypertension artérielle primaire ou secondaire connue ou découverte à l’inclusion sur 3 mesures après une période de repos de 15 minutes (PAS≥140 mmHg et/ou PAD≥90 mmHg)
    • Tabagisme au jour de l’inclusion (>5 cigarettes/jour)
    • Hypercholestérolémie sévère (cholestérol total>2,5 g/L)
    • Pratique du sport de façon intensive (≥ 1 heure/jour)
    • Insuffisance rénale définie par une clairance de la créatinine ≤ 60 ml/min/1,73 m² avec la formule de Cockroft et Gault
    • Insuffisance hépatique connue
    • Insuffisance cardiaque connue ou suspectée sur la notion d’épisode congestif
    • Fibrillation auriculaire
    • Troubles de conduction de haut degré (Maladie du sinus, bloc sino-auriculaire, bloc auriculo-ventriculaire du 2e et 3e degré)
    • QT corrigé par la formule de Bazett anormal (QTc > 450 ms (homme) ou > 470 ms (femme)).
    • Porteurs d’un stimulateur cardiaque
    • Toute autre pathologie susceptible d’altérer l’état du système cardio-vasculaire : toute pathologie cardiaque ou non, active ou ancienne avec séquelles qui selon l’avis de l’investigateur s’accompagne d’un risque d’atteinte cardiaque ou vasculaire
    • Pathologie rétinienne connue
    • Administration de tous médicaments (sauf contraceptif oral, paracétamol ou avis contraire de l’investigateur) listés en annexe 2 dans les 4 semaines qui précèdent la visite d’inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Magnitude of change in wall viscosity of the common carotid artery after repeated administration of ivabradine and placebo in healthy subjects.
    Différence d'amplitude de la variation de la viscosité de l’artère carotide primitive entre l’ivabradine et un placebo chez des sujets sains.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This study contain five visits. At each visit, from the first (V1) to the fourth visit (V4), the primary criteria will be evaluated. In fact, vascular echotracking and applanation tonometry will enable us to evaluate the primary criteria during the first(two to ten days after inclusion visit), second (6 days after V1), third (12 to 16 days after V2) and fourth (6 days after V3) visit.
    E.5.2Secondary end point(s)
    - Magnitude of change in diameter, intima-media thickness and carotid distensibility and carotid to femoral pulse wave velocity after repeated administration of ivabradine and placebo in healthy subjects .
    - Magnitude of change in plasma levels of biomarkers of endothelial function and in endothelial shear stress after repeated administration of ivabradine and placebo in healthy subjects
    - Magnitude of change in peripheral and central pressures, augmentation index, Buckberg index and cardiac output after repeated administration of ivabradine and placebo in healthy subjects.
    - Relationship between age and the magnitude of change in all previous parameters after repeated administration of ivabradine and placebo, in healthy subjects.
    - Différence d'amplitude de la variation du diamètre, de l'épaisseur intima-média et de la distensibilité carotidienne et de la vitesse de l'onde de pouls carotido-fémorale entre l’ivabradine et un placebo chez des sujets sains.
    - Différence d'amplitude de la variation des concentrations plasmatiques des marqueurs biologiques de fonction endothéliale et de la contrainte de cisaillement endothéliale entre l’ivabradine et un placebo chez des sujets sains.
    - Différence d'amplitude de la variation des pressions centrales et périphériques de l’index d’augmentation, de l’index de Buckberg et du débit cardiaque entre l’ivabradine et un placebo chez des sujets sains.
    - Relation entre l’âge et la différence d’amplitude de variation, entre l’ivabradine et un placebo, de l’ensemble des paramètres précédents chez des sujets sains.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The examinations which will allow to assess these secondary criteria are :
    -Applanation tonometry
    -Vascular echo-tracking
    -Automated velocimetry
    -Biological examination
    -High Resolution Doppler
    -Vascular oscillometry
    -Bio-impedancemetry
    This study contain five visits. At each visit, from the first (V1) to the fourth visit (V4), the secondary cirteria will be evaluated :
    -First visit (V1), two to ten days after inclusion visit,
    -Second visit(V2), 6 days after V1, -Third visit (V3), 12 to 16 days after V2,
    -Fourth visit (V4), 6 days after V3.
    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 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    Dernière visite dernier patient
    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 months20
    E.8.9.1In the Member State concerned days
    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: 30
    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 Yes
    F.3.2Patients No
    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 state30
    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)
    None
    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 Decision2015-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-15
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