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    Summary
    EudraCT Number:2011-004744-22
    Sponsor's Protocol Code Number:GERICO11/PACS10
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-004744-22
    A.3Full title of the trial
    Adjuvant systemic treatment for oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70 according to Genomic Grade (GG): chemotherapy + endocrine treatment versus endocrine treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) multicentre phase III trial
    Traitement adjuvant systémique du cancer du sein avec récepteurs aux œstrogènes-positifs et HER2-négatif de la femme de plus de 70 ans en fonction du grade génomique (GG) : chimiothérapie et hormonothérapie versus hormonothérapie seule. Etude multicentrique de phase III des groupes UNICANCER GERICO et UCBG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.4.1Sponsor's protocol code numberGERICO11/PACS10
    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 SponsorUNICANCER
    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 supportTeva
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointChristine ORSINI
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number01 71 93 67 07
    B.5.5Fax number01 44 23 55 69
    B.5.6E-mailc-orsini@unicancer.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 DOXORUBICINE
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE 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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 DOCETAXEL
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS GROUP PTC
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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: 3
    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 ENDOXAN
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires baxter
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 1000
    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: 4
    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 MYOCET
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon Europe
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316-40-9
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70
    cancer du sein avec récepteurs aux œstrogènes-positif et HER2-négatif de la femme de plus de 70 ans
    E.1.1.1Medical condition in easily understood language
    ER-positive HER2-negative breast carcinoma
    Cancer du sein RE+ et HER2-
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    _
    Evaluation du bénéfice de la chimiothérapie adjuvante sur la survie globale (SG) dans le sous-groupe de patientes âgées présentant un risque de rechute élevé selon le Grade Génomique (GG).
    E.2.2Secondary objectives of the trial
    _
    -Bénéfice sur la SG en prenant en compte les risques compétitifs de mortalité (comorbidités, autonomie, statut nutritionnel).
    -Survie spécifique et non spécifique
    -Survie sans récidive (DFS).
    -Survie sans événements (EFS)
    -Toxicité (NCI-CTC V4.0).
    -Evaluation gériatrique ; Validation du questionnaire G8 dans la population âgée porteuse d’un cancer du sein
    -Validation prospective du score de mortalité à 4 ans et de sa version française dans une population âgée cancéreuse.
    -Comparer la qualité de vie relative à la santé (QLQ C30 et échelle spécifique sujet âgé ELD15)
    -Analyse Q-TwiST.
    -Acceptabilité du traitement
    -Valeur pronostique du GG en RT-PCR et performance du test pour la population âgée, comparé aux critères standards histologiques classiques (pN, grade histologique, index mitotique et score Ki67).
    -Etude coût-efficacité
    -Suivi de la cohorte non traitée par chimiothérapie adjuvante (dont non éligibilité due au GG).

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    _
    Analyses du transcriptome et du protéome ; Analyse tissue Array - Sérothèque et Tumorothèque (Echantillon tumoral fixé en formol et inclus en paraffine obligatoire et congelé optionnel).
    E.3Principal inclusion criteria
    1) Women aged ≥ 70 yo,
    2) Histologically proven invasive breast cancer (regardless of the type),
    3) Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection,
    4) Any N status (pN+ or pN0),
    5) No clinically or radiologically detectable metastases (M0),
    6) Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),
    7) HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
    8) Normal haematological function prior to GG evaluation: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,
    9) Normal hepatic function prior to GG evaluation: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN,
    10) Creatinine clearance prior to GG evaluation (MDRD formula) ≥ 40 mL/min,
    11) PS (ECOG) ≤ 2,
    12) Patient able to comply with the protocol,
    13) Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection,
    14) Patients must be affiliated to a Social Health Insurance.
    Of note:
    - there will be no high selection according to previous medical history in order to capture the
    whole population and to be able to depict heterogeneity of ageing from 70;
    - controlateral breast cancer, invasive BC after ductal carcinoma in situ or isolated local invasive relapse when a question of adjuvant systemic treatment is raised are all eligible cases;
    - patients with multifocal or bilateral disease are eligible and followed in the study according to worst GG.
    1. Femme âgée d’au moins 70 ans,
    2. Cancer du sein invasif prouvé histologiquement (quel que soit son type),
    3. Chirurgie complète réalisée avant l’inclusion de la patiente dans l’étude : mastectomie radicale modifiée ou chirurgie mammaire conservatrice, associée soit à une procédure de ganglion sentinelle, soit à un curage axillaire,
    4. pN+ ou pN0,
    5. Absence de métastases cliniquement ou radiologiquement détectables (M0),
    6. Récepteurs aux œstrogènes positifs (RE+), défini par un taux ≥10% en immunohistochimie (IHC),
    7. Statut HER2 négatif (HER2-) défini comme IHC score 0 ou 1+, ou IHC score 2+ et FISH/SISH/CISH négatif,
    8. Fonction hématologique satisfaisante : PNN≥1.500/mm3 ; plaquettes≥100.000/mm3 ; Hb>9 g/dl
    9. Fonction hépatique satisfaisante : bilirubine totale ≤ 1.25 ULN ; ASAT and ALAT ≤ 1.5 ULN phosphatases alcalines ≤ 3 ULN,
    10. Clairance de la créatinine (formule MDRD) ≥ 40 mL/min,
    11. PS (ECOG) ≤ 2,
    12. Patientes en mesure de se conformer au protocole,
    13. Patientes ayant signé un consentement éclairé avant tout bilan spécifique à l’étude, incluant l’accord pour l’utilisation du matériel tumoral archivé en vue du screening génomique et de la collection de données,
    14. Patiente affiliée à un régime de sécurité sociale ou qui bénéficie d’un tel régime.

    A noter :
    - Il n'y aura pas de sélection selon les antécédents médicaux afin de capturer l'ensemble de la population et être en mesure de représenter l'hétérogénéité du vieillissement à partir de 70 ans.
    - Les patientes présentant un cancer du sein controlatéral ou un cancer du sein infiltrant (suite d’un carcinome intracanalaire in situ ou récidive locale isolée) sont éligibles pour l’étude à partir du moment où la question d’un traitement adjuvant systémique est posée.
    - Les patientes présentant une tumeur multifocale ou bilatérale sont éligibles dans l’étude. En cas de discordance sur le résultat du grade génomique pour les différents échantillons, le grade le plus défavorable est pris en compte pour la suite de l’étude.
    E.4Principal exclusion criteria
    1) Any metastatic impairment,
    2) Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
    3) ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
    4) HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive,
    5) Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,
    6) PS (ECOG) ≥ 3,
    7) Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
    8) Patient deprived of freedom or under tutelage,
    9) Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.
    1. Toute lésion métastatique
    2. Toute tumeur ≥ T4a (UICC1987) (envahissement cutané, adhérence profonde, cancer du sein inflammatoire),
    3. Récepteurs aux œstrogènes négatifs, défini par un taux <10% en immunohistochimie (IHC),
    4. Surexpression de HER 2 définie comme IHC score 3+ ou score 2+ et FISH/SISH/CISH positif,
    5. Toute chimiothérapie, hormonothérapie ou radiothérapie pour le cancer actuel avant chirurgie,
    6. PS (ECOG) ≥ 3,
    7. Contre-indication aux médicaments de l’étude (incluant mais non limitée à une sensibilité à un des produits de l’étude ou à ses composants),
    8. Patiente privée de liberté ou patiente sous tutelle,
    9. Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)
    The OS is defined as the interval between the date of randomization and the date of death from any cause.
    Taux de survie globale avec 4 ans de suivi (suivi médian = 4 ans)
    La survie globale (SG) est définie par l’intervalle entre la date de randomisation et la date de décès quelle qu’en soit la cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    _
    Survie spécifique

    Survie sans rechute

    Survie sans événement

    Toxicité définie selon les critères NCI-CTC V 4.0

    Evaluation Gériatrique

    Valeur prédictive de l’index d’espérance de vie à 4 ans pour les personnes âgées

    Qualité de vie

    Analyse Q-TwiST

    Evaluation de l’acceptabilité du traitement

    Utilité de l’évaluation du grade génomique

    Analyse coût-efficacité pour évaluer l'impact médico-économique de la chimiothérapie adjuvante chez les femmes de plus de 70 en fonction du grade génomique GG.

    Suivi de la cohorte de patientes âgées présentant un cancer du sein non traitées avec la chimiothérapie adjuvante (y compris non éligibilité en raison du grade génomique).
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    _
    Qualité de vie, Analyses du transcriptome et du protéome.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 years8
    E.8.9.1In the Member State concerned months
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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 Decision2013-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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