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    Summary
    EudraCT Number:2015-003119-39
    Sponsor's Protocol Code Number:38RC15.175
    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:2016-02-25
    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 number2015-003119-39
    A.3Full title of the trial
    effects of a short therpay of zolpidem with support servo-ventilation versus placebo in patients with central sleep apnea with chronic heart failure
    Bénéfice sur l’observance a un mois d’une ventilation servo assistée initiée sous hypnotique (Zolpidem) versus placebo chez des patients avec dysfonction cardiaque porteurs d’un syndrome d’apnées centrales du sommeil
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    effects of a short therpay of zolpidem with support servo-ventilation versus placebo in patients with central sleep apnea with chronic heart failure
    Effet d'un traitement court accompagnant une ventilation servo assisté chez des patients avec dysfonction cardiaque porteurs d’un syndrome d’apnées centrales du sommeil
    A.3.2Name or abbreviated title of the trial where available
    ZODIAC
    ZODIAC
    A.4.1Sponsor's protocol code number38RC15.175
    A.5.4Other Identifiers
    Name:NoNumber:No
    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 SponsorCentre Hospitalier Universitaire de Grenoble
    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 supportCentre hospitalier Universitaire de GRENOBLE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la recherche Clinique
    B.5.2Functional name of contact pointARC promoteur
    B.5.3 Address:
    B.5.3.1Street AddressCS 1217
    B.5.3.2Town/ cityGRENOBLE
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number+330476 76 84 55
    B.5.5Fax number+330476 76 52 21
    B.5.6E-mailMCoutard@chu-grenoble.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 stilnox
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis 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.3.1Product namezolpidem
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboBuccal 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
    chronic heart failure and central sleep apnea
    patients avec dysfonction cardiaque porteurs d'un syndrome d'apnées centrales du sommeil
    E.1.1.1Medical condition in easily understood language
    chronic heart failure and central sleep apnea
    patients avec dysfonction cardiaque porteurs d'un syndrome d'apnées centrales du sommeil
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10040979
    E.1.2Term Sleep apnoea syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10019276
    E.1.2Term Heart disease, unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    please report to the french version
    Evaluer l’effet de l’initiation d’une ventilation servo-asssitée (VSA) sous traitement de 14 jours par ZOLPIDEM, versus placebo, chez des patients porteurs d’un Syndrome d’apnées centrales du sommeil (SACS)
    E.2.2Secondary objectives of the trial
    please report to the french version
    Evaluer l’observance à 3 et 12 mois
    Impact de la prise de Zolpidem sur les symptômes résiduels
    Impact de la prise de Zolpidem sur le contrôle du SACS par la ventilation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    please report to the french version
    - Diagnostic de SACS sur une polygraphie (PG) ou une polysomnograhie (PSG) défini par :
    o IAH ≥ 15/h
    o Au moins 50% d’évènements centraux
    - Dysfonction cardiaque (IC) définie par une dysfonction diastolique en échographie transthoracique (ETT) (FEVG visuelle > 45%) connue depuis plus de 12 semaines et stable cliniquement depuis au moins 4 semaines
    - Observance inférieure à 3 heures après 7 jours de mise en place d’une VSA
    - Patient de sexe masculin ou féminin âgé de plus de 18 ans lors de l’inclusion initiale
    - Patient volontaire pour participer à la recherche après information adéquate et remise de la note d’information
    - Patient affilié à la sécurité sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    please report to the french version
    - Traitement par pression positive continue (PPC) antérieur à moins d’un an
    - FEVG ≤ 45%
    - Episode d’insuffisance respiratoire aiguë ou d’insuffisance cardiaque dans le mois précédent l’inclusion
    - Allergie ou contre-indication au ZOLPIDEM
    - Personne privée de liberté par décision judiciaire ou administrative, personne faisant l’objet d’une mesure de protection légale (femmes enceintes ou allaitant, patient sous tutelle ou curatelle) Article L1121-8
    - Période d’exclusion pour d’autres études
    E.5 End points
    E.5.1Primary end point(s)
    please report to the french version
    Evaluation de l’observance de la VSA (temps d’utilisation machine) à un mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    please report to the french version
    à 1 mois et à 1 an
    E.5.2Secondary end point(s)
    please report to the french version
    Evaluer le temps d’utilisation machine à 3 et 12 mois
    Evaluer la somnolence par score d’Epworth et l’asthénie par l’échelle de Pichot
    Evaluer les paramètres machine et l’IAH résiduel
    E.5.2.1Timepoint(s) of evaluation of this end point
    please report to the french version
    à 3 mois et à 12 mois
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 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
    la date de dernière visite du 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 months48
    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) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    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 state48
    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
    non
    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 Decision2015-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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