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    Summary
    EudraCT Number:2015-003521-34
    Sponsor's Protocol Code Number:CHUBX2015/14
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-08
    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 number2015-003521-34
    A.3Full title of the trial
    Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine
    Diminution des symptômes de la cardiomyopathie hypertrophique par le chlorhydrate de midodrine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine
    Diminution des symptômes de la cardiomyopathie hypertrophique par le chlorhydrate de midodrine
    A.3.2Name or abbreviated title of the trial where available
    Light-CARMIDO
    Light-CARMIDO
    A.4.1Sponsor's protocol code numberCHUBX2015/14
    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 de Bordeaux
    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 de Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointREC
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number+33557821097
    B.5.5Fax number+33557824926
    B.5.6E-mailvincent.dejarnac@chu-bordeaux.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 Gutron 2,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderTAKEDA FRANCE SAS
    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 INNMIDODRINE HYDROCHLORIDE
    D.3.9.1CAS number 3092-17-9
    D.3.9.4EV Substance CodeSUB08954MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.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 Yes
    D.2.1.1.1Trade name Gutron 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderTAKEDA FRANCE SAS
    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 INNMIDODRINE HYDROCHLORIDE
    D.3.9.1CAS number 3092-17-9
    D.3.9.4EV Substance CodeSUB08954MIG
    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
    Hypertrophic cardiomyopathy
    Cardiomyopathie hypertrophique
    E.1.1.1Medical condition in easily understood language
    Hypertrophic cardiomyopathy
    Cardiomyopathie hypertrophique
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of chlorydrate of midodrine effects to placebo for improving walk distance test on day 15.
    Comparer les résultats obtenus au test de marche de 6 minutes (6MWT) à 2 semaines (J15), chez des patients CMH, avec obstruction à l’effort, entre deux groupes parallèles :
    - traitement par chlorydrate de midodrine,
    - placebo.
    E.2.2Secondary objectives of the trial
    analysis and comparison of LVOTO using rest and exercise echocardiography in the two groups (treatment and placebo), evolution of NYHA functional class, quality of life tests, BNP and treatment tolerance in the two groups.
    - Comparer les résultats au test 6MWT, entre traitement par chlorhydrate de midodrine et placebo, à J30.
    - Etudier la tolérance au traitement
    - Etudier les paramètres cliniques et biologiques suivants à J15 et J30 :
    - la mesure de l’obstruction intra ventriculaire au repos et à l’effort, par évaluation Doppler du paramètre d’obstruction intra-ventriculaire,
    - la classe fonctionnelle NYHA (1 à 4),
    - le score au questionnaire de qualité de vie standardisé KCCQ et EQ5D,
    - le score de douleur CCS,
    - le BNP (peptide natriurétique de type B),
    - l’échocardiographie d’effort, avec :
    • mesures des pressions artérielles au repos et à l’effort
    • volume télédiastolique du VG
    • volume télésystolique du VG
    • hyperkinésie (FEVG)
    • paramètres hémodynamiques non invasifs (pressions de remplissage du VG et pressions pulmonaires)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults aged 18-80 years of both sexes,
    - Patients carrying a typical or atypical hypertrophic cardiomyopathy diagnosed by cardiac imaging (echocardiography and MRI) and / or genetic testing or family history,
    - Obstruction per-effort treadmill (in aortic obstruction> 50 mmHg measured continuously aligned with the Doppler aortic ejection)
    - Positive response (<50 mmHg obstruction) test "Leg-lifting" of rest and / or immediate post-exercise
    - Symptomatic to stress in daily life: dyspnea NYHA 2-3, non coronary chest pain, fainting effort,
    - Exploitable ultrasonic window,
    - Sinus rhythm,
    - Optimal medical treatment,
    - For women of childbearing potential, effective contraception and required negative pregnancy test,
    - Intent Consent form signed by the patient after having read the information letter,
    - Patient affiliated to national health system.
    - Adultes de 18 à 80 ans des deux sexes,
    - Patients porteurs d’une cardiomyopathie hypertrophique typique ou atypique diagnostiquée par imagerie cardiaque (échocardiographie et IRM) et/ou tests génétiques ou histoire familiale,
    - Obstruction per-effort sur tapis de marche (obstruction sous aortique > 50 mmHg mesuré en doppler continu aligné sur l’éjection aortique),
    - Réponse positive (obstruction < 50 mmHg) au test « Leg-lifting » de repos et/ou post-effort immédiat
    - Symptomatique à l’effort dans la vie quotidienne : dyspnée NYHA 2-3, douleurs thoraciques non coronarienne, lipothymies d’effort,
    - Fenêtre ultrasonore exploitable,
    - Rythme sinusal,
    - Traitement médical optimal,
    - Pour les femmes en âge de procréer, contraception efficace exigée et test de grossesse négatif,
    - Consentement signé par le patient après avoir lu la notice d’information,
    - Patient affilié à la sécurité sociale.
    E.4Principal exclusion criteria
    - Minor Patient,
    - Taking Gutron® earlier,
    - Extra-cardiac pathology limiting life expectancy to less than a year,
    - Inability to consent or refusal to sign the consent,
    - Pregnant and breastfeeding women,
    - Hypertrophy secondary to hypertensive or valvular disease,
    - Permanent atrial fibrillation,
    - Threatening ventricular rhythm disorders (ventricular doublets, bigeminy, bursts TV) without a pacemaker,
    - Severe Coronary Artery Disease,
    - Hypertension unbalanced by the usual therapeutic,
    - Severe heart disease (Fe <40% or severe elevated filling pressures, pulmonary hypertension> 60 mmHg)
    - Narrow Angle Glaucoma,
    - Obliterative vasculopathy severe,
    - Vasospasm,
    - Thyrotoxicosis,
    - Pheochromocytoma,
    - Severe renal impairment <30ml / min,
    - Raynaud's disease,
    - History of CHD pain,
    - Non-selective MAO inhibitors (iproniazid, nialamide) or indirect sympathomimetic (ephedrine, methylphenidate, phenylephrine, pseudoephedrine), or digitalis,
    - Any procedure modifying the venous return: vein stripping / venotomy the lower limbs,
    - Participation in another biomedical research study,
    - Criteria relating to the regulation: persons under safeguard justice, physical and / or psychological severely impaired, which according to the investigator, may affect the compliance of participating in the study
    - Patient mineur,
    - Prise antérieure de Gutron®,
    - Pathologie extra-cardiaque limitant l’espérance de vie à moins d’un an,
    - Impossibilité de donner son consentement ou refus de signer le consentement,
    - Femmes enceintes et allaitantes,
    - Hypertrophie hypertensive ou secondaire à une valvulopathie,
    - Fibrillation atriale permanente,
    - Troubles du rythme ventriculaire menaçants (doublets ventriculaires, bigéminisme, salves de TV) non appareillés,
    - Coronaropathie sévère,
    - Hypertension artérielle non équilibrée par les thérapeutiques habituelles,
    - Cardiopathie sévère (Fe<40% ou élévation sévère des pressions de remplissage, HTAP > 60 mmHg),
    - Glaucome à angle fermé,
    - Vasculopathie oblitérante sévère,
    - Vasospasme,
    - Thyrotoxicose,
    - Phéochromocytome,
    - Insuffisance rénale sévère < 30ml/min,
    - Maladie de Raynaud,
    - Antécédents de douleurs d’origine coronaire,
    - IMAO non sélectifs (iproniazide, nialamide) ou sympathomimétiques indirects (éphédrine, méthylphénidate, phényléphrine, pseudoéphédrine) ou digitaliques,
    - Toute procédure modifiant le retour veineux : stripping veineux/veinotomie des membres inférieurs,
    - Participation dans une autre étude de recherche biomédicale,
    - Critères relatifs à la réglementation : personnes placées sous sauvegarde de justice, santé physique et/ou psychologique sévèrement altérée, qui selon, l’investigateur, peut affecter la compliance du participant à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Distance covered in meters during the 6-minute walk test (6MWT) at Day 15.
    La distance parcourue, en mètres, lors du test de marche de 6 minutes (6MWT) à J15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Jour 15
    E.5.2Secondary end point(s)
    - The distance covered in meters during the 6-minute walk test (6MWT) at D30.
    - The measurement of intra ventricular obstruction at rest and during exercise, Doppler evaluation of intraventricular obstruction parameter,
    - NYHA functional class (1-4)
    - The score at standardized quality of life questionnaires KCCQ and EQ5D
    - CCS pain score,
    - BNP,
    - The stress echocardiography with measurement of blood pressure at rest and during exercise
    - Safety of treatment.
    - la distance parcourue, en mètres, lors du test de marche de 6 minutes (6MWT) à J30.
    - la mesure de l’obstruction intra ventriculaire au repos et à l’effort, par évaluation Doppler du paramètre d’obstruction intra-ventriculaire,
    - la classe fonctionnelle NYHA (1 à 4),
    - le score au questionnaire de qualité de vie standardisé KCCQ et EQ5D
    - le score de douleur CCS,
    - le BNP,
    - l’échocardiographie d’effort, avec mesures des pressions artérielles au repos et à l’effort
    - la tolérance du traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30
    Jour 30
    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 No
    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) 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.8.2.4Number 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 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
    DVDP
    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 months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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)
    It will be proposed to patients with a positive response to the walk test and quality of life tests to continue midodrine hydrochloride under medical surveillance for three months: monthly phone call, cardiology consultation at CHU Bordeaux after 3 months.
    A l’issue de cette visite, il sera proposé aux patients ayant une réponse positive au test de marche et aux tests de qualité de vie de poursuivre le chlorhydrate de midodrine sous surveillance médicale pendant 3 mois : appel téléphonique mensuel, consultation cardiologique au CHU de Bordeaux à 3 mois.
    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 Opinion2015-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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