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    Summary
    EudraCT Number:2010-018316-32
    Sponsor's Protocol Code Number:D589GC00002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-09-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-018316-32
    A.3Full title of the trial
    A Phase 2, randomized, blinded, 5-period cross-over, placebo and activecontrolled,
    multicenter, dose-finding study of single doses of formoterol 2.25 μg, 4.5 μg, and 9 μg delivered via Symbicort pMDI and Foradil® Aerolizer® 12 μg evaluating the bronchodilating effects and safety in children, ages 6 to <12 years, with asthma who are receiving background treatment with budesonide pMDI 160 μg bid
    A.4.1Sponsor's protocol code numberD589GC00002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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 No
    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 nameSymbicort pMDI 80/2.25
    D.3.2Product code Symbicort pMDI 80/2.25
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol fumarate
    D.3.9.1CAS number 43229-80-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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 nameSymbicort pMDI 80/4.5
    D.3.2Product code Symbicort pMDI 80/4.5
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Foradil® Aerolizer® 12 μg
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas and Novartis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 No
    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 nameBudesonide pMDI 40
    D.3.2Product code Budesonide pMDI 40
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 nameBudesonide pMDI 80
    D.3.2Product code Budesonide pMDI 80
    D.3.4Pharmaceutical form Pressurised inhalation*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPressurised inhalation, suspension
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the bronchodilating effects of 3 doses of formoterol given in combination with budesonide as Symbicort pMDI in a population of asthmatic children demonstrated to be stable on a medium dose range of ICS therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    • evaluate the bronchodilating effect of Foradil Aerolizer (formoterol fumarate
    inhalation powder; Schering) 12 μg
    • determine the systemic exposure to formoterol following administration of formoterol 2.25 μg, 4.5 μg, and 9 μg, given in combination with budesonide as Symbicort pMDI or Foradil Aerolizer 12 μg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent prior to conducting any studyspecific procedures.
    2. Is between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 1).
    3. Has a documented clinical diagnosis of asthma as defined by the American
    Thoracic Society (ATS, ie, “a disease characterized by increased responsiveness of
    the trachea and bronchi to various stimuli and manifested by widespread narrowing
    of the airway that changes in severity either spontaneously or as a result of
    therapy”) for at least 6 months prior to Visit 1.
    4. Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled LABA of ≥60%
    and ≤85% of predicted normal. Polgar predicted normal standards will be used for
    all patients. If the patient is taking a fixed combination of ICS and LABA, the patient is to be placed on a comparable dose of ICS without the addition of a LABA
    at least 48 hours prior to spirometry testing.
    5. Demonstrated reversibility of FEV1 of ≥15% from pre-albuterol level within 15 to
    30 minutes after administration of a standard dose of albuterol at Visit 2 (albuterol
    MDI, 90 μg per inhalation, 2 to 4 actuations, with or without a spacer, or up to
    2.5 mg of nebulized albuterol). Patients can return to the clinic once within 7 days
    for a 2nd attempt at reversibility if the first attempt was ≥12 % but <15%. This 2nd
    attempt must be done in the morning. Until the reversibility criterion is met, the
    patient must not be withdrawn from his/her usual ICS and must not be dispensed
    run-in medication, study reliever medication, or patient notebook and diary. The
    run-in period cannot start until after the FEV1 and reversibility criteria have been
    met.
    6. Has required and received treatment with a consistent daily dose of ICS within the
    corresponding dose range listed below for at least 4 weeks prior to Visit 1. If the
    patient is not under the care of the investigator, documentation of ICS use by
    pharmacy records or copies of the prescribing Health Care Practitioner’s records are
    required, to verify ICS use.
    − Beclomethasone dipropionate HFA pMDI: 160 - 320 μg/day
    − Budesonide: 360 - 540 μg/day
    − Budesonide (nebulized): 1000 μg/day
    − Flunisolide: 1000 - 1250 μg/day
    − Flunisolide HFA: 320 μg/day
    − Fluticasone 176 - 352 μg/day (HFA pMDI) or 200-400 μg/day (Diskus)
    − Triamcinolone acetonide: ≥600 - 900 μg/day
    − Ciclesonide: 320 - 480 μg/day
    − Mometasone: 440 μg/day
    Note: Other non-steroidal asthma medications (eg, leukotriene modifiers, mast
    cell stabilizers) could have been used in combination with any of the above and
    would not impact a patient’s eligibility. After providing written informed
    consent for withdrawal of medication and at least 48 hours prior to spirometry
    testing, potential patients maintained on a fixed combination of ICS and LABA
    should be switched to a comparable dose of ICS without the addition of a longterm
    β2-agonist. This change will not be considered a change in the dose of
    maintenance ICS.
    7. If receiving inhalant allergen immunotherapy, the patient must have been on a
    stable maintenance regimen for at least 6 weeks and is expected to remain on
    immunotherapy throughout the study.

    Randomization criteria (Visit 3)
    1. Has discontinued use of all asthma medications, including all formulations of
    β2-agonists, following Visit 2 (or since meeting the FEV1/reversibility criteria, if
    met after Visit 2) and used only the open-label run-in medication and reliever
    medication provided since Visit 2.
    Has a pre-dose morning clinic FEV1 measured at least 6 hours after the last dose of
    inhaled SABA with <12% variation from the pre-dose, baseline FEV1(L)
    measurement obtained at the visit where the patient showed reversibility of at least
    15%.
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the following exclusion criteria are fulfilled:
    1. Has been hospitalized for >24 hours at least once or has required emergency
    treatment more than once in an emergency department (or equivalent) for acute
    deterioration of asthma during the 6 months prior to Visit 1.
    2. Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
    3. Has participated in another investigational drug study during the 4 weeks prior to
    Visit 1.
    4. Has participated in a prior Symbicort clinical study within the previous 12 months.
    5. Is receiving treatment with a β-blocker (including eye drops).
    6. Has taken Xolair®, or any other monoclonal or polyclonal antibody therapy, for any
    reason within the 6 months prior to Visit 2.
    7. Positive pregnancy test at any time during the study.
    8. Has any significant disease or disorder, which, in the opinion of the investigator,
    may either put the patient at risk because of participation in the study, or influence
    the results of the study, or the patient’s ability to participate in the study.
    9. Has a planned hospitalization during the study.
    10. Has any clinically relevant abnormal findings on physical examination or vital signs
    at baseline visit, which, in the opinion of the investigator, may put the patient at risk
    because of his/her participation in the study.
    11. Has known or suspected hypersensitivity to study medications and/or their
    excipients.

    Exclusion criteria at randomization (Visit 3)
    1. Has been treated with systemic corticosteroids (eg, oral, parenteral, or rectal) for
    any reason during the run-in period or at time of Visit 3.
    2. Has been hospitalized for >24 hours or has required emergency treatment in an
    emergency department (or equivalent) for acute deterioration of asthma during the
    run-in period.
    3. Has a respiratory infection or other viral/bacterial illness or is recovering from such
    an illness at the time of Visit 3, which, in the investigator’s opinion, will interfere
    with the patient’s lung function and/or ability to perform serial spirometry.
    E.5 End points
    E.5.1Primary end point(s)
    Outcome variable(s):
    • Efficacy
    - The primary efficacy variable will be AUC0-12 for FEV1.
    - The secondary efficacy variables are FEV1 at 12 hours after study medication
    inhalation and the maximal FEV1 for the 12-hour study period.
    • Pharmacokinetics
    - 12-hour urine collection to measure unchanged formoterol
    • Safety
    - Incidence of adverse events, discontinuations due to adverse events, serious
    adverse events
    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 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 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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned7
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The last visit of the last patient undergoing the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 86
    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 Decision2010-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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