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    Summary
    EudraCT Number:2011-004668-31
    Sponsor's Protocol Code Number:SPD503-318
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-12
    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 ConcernedIreland - HPRA
    A.2EudraCT number2011-004668-31
    A.3Full title of the trial
    A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study to enable patients to continue to receive Guanfacine Hydrocloride Extended Release tablets after completing either study SPD503-315 or SPD503-316.
    A.4.1Sponsor's protocol code numberSPD503-318
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/186/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire Pharmaceutical Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportShire Pharmaceutical Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceutical Development Ltd
    B.5.2Functional name of contact pointClinical Programs Leadership
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityBasingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441256894000
    B.5.5Fax number441256894707
    B.5.6E-mailcpmailbox@shire.com
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNGuanfacine Hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNGuanfacine Hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNGuanfacine Hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNGuanfacine Hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Attention Deficit/Hyperactivity Disorder (ADHD)
    E.1.1.1Medical condition in easily understood language
    Attention Deficit/Hyperactivity Disorder (ADHD)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 long term safety of SPD503.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    To assess the maintenance of efficacy of SPD503 seen in antecedent studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For subjects enrolling from antecedent Study SPD503-315:
    Subjects will be eligible if they met the response criteria for entry into Phase 2, were
    randomized, and completed Phase 2 or withdrew early because the protocol-defined treatment
    failure criteria was met.
    For subjects enrolling from antecedent Study SPD503-316:
    Children age 6-12, regardless of treatment group, must complete 10 weeks of double-blind
    treatment, reach Visit 15/Final, and complete the 2-week dose taper.
    Adolescents age 13 and older, regardless of treatment group, must complete 13 weeks of
    double-blind treatment, reach Visit 15/Final, and complete the 2-week dose taper.
    For all subjects:
    1. For subjects where Study SPD503-318 was not available at the time of subject’s
    final visit in the antecedent study (SPD503-315 or SPD503-316), subject may still
    screen unless they are well-controlled on another ADHD medication with
    acceptable tolerability and the parent/caregiver is satisfied with the current ADHD
    medication.
    2. Subject satisfied all entry criteria for the antecedent study (SPD503-315 or
    SPD503-316).
    3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of
    age or <9 years of age and is post-menarchal, must have a negative serum beta
    Human Chorionic Gonadotropin (β-hCG) pregnancy test at the Screening Visit
    (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and
    agree to comply with any applicable contraceptive requirements of the protocol.
    4. Subject’s parent or legally authorised representative (LAR) must provide signature
    of informed consent, and there must be documentation of assent (if applicable) by
    the subject indicating that the subject is aware of the investigational nature of the
    study and the required procedures and restrictions in accordance with the
    International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)
    Guideline E6 and applicable regulations, before completing any study-related
    procedures.
    5. Subject and parent/LAR are willing, able, and likely to fully comply with all the
    testing and requirements defined in this protocol, including oversight of dosing.
    Specifically, the parent/LAR must be available upon awakening, to dispense the
    dose of investigational product for the duration of the study.
    6. Subject has a supine and standing blood pressure (BP) measurement within the
    95th percentile for age, sex, and height.
    7. Subject is functioning at an age-appropriate level intellectually, as deemed by the
    Investigator.
    8. Subject is able to swallow intact tablets.
    E.4Principal exclusion criteria
    1. Subject has any current, controlled (requiring a prohibited medication or behavioural
    modification program) or uncontrolled, co-morbid psychiatric diagnosis [except
    oppositional defiant disorder (ODD)], including any severe comorbid Axis II disorders
    or severe Axis I disorders such as post traumatic stress disorder (PTSD), bipolar
    illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder
    (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime
    history of bipolar illness, psychosis or conduct disorder that, in the opinion of the
    Investigator, contraindicate treatment with SPD503 or confound efficacy or safety
    assessments. Review the Kiddie Schedule for Affective Disorders and Schizophrenia –
    Present and Lifetime version (K-SADS-PL) from the antecedent study to confirm
    diagnosis, if necessary.
    2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for
    protocol non-adherence, subject non-compliance, an adverse event (AE), serious
    adverse event (SAE), or withdrawal by subject.
    3. Subject experienced any clinically significant AE in a prior SPD503 study (SPD503-
    315 or SPD503-316) that, in the opinion of the Investigator, would preclude exposure
    to SPD503.
    4. Clinically important abnormality on urine drug and/or alcohol screen at the Screening
    Visit (Visit 1).
    5. Subject has taken any investigational medicinal product as follows: last dose of
    investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit
    (Visit 2); investigational product in Study SPD503-316 within 30 days prior to the
    Baseline Visit (Visit 2); any other investigational product within 30 days prior to the
    Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to
    Baseline Visit (Visit 2).
    6. Subject is significantly overweight based on Center for Disease Control and
    Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit
    (Visit 1). Significantly overweight is defined as a BMI >95th percentile.
    7. Children aged 6 to 12 years with a body weight of less than 25.0kg or adolescents
    aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit
    (Visit 1).
    8. Subject has any condition or illness including clinically significant abnormal
    laboratory values at the Screening Visit (Visit 1) which, in the opinion of the
    Investigator, represents an inappropriate risk to the subject and/or could confound the
    interpretation of the study.
    9. Subject is currently considered a suicide risk in the opinion of the Investigator, has
    previously made a suicide attempt, or has a prior history of, or is currently
    demonstrating active suicidal ideation. Subjects with intermittent passive suicidal
    ideation are not necessarily excluded based on the assessment of the Investigator.
    10. Subject has clinically significant ECG findings, as judged by the Investigator with
    consideration of the central ECG laboratory’s interpretation, at the Baseline Visit
    (Visit 2).
    11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant
    intolerance to guanfacine hydrochloride, or any components found in SPD503.
    12. Subject has a history of alcohol or other substance abuse or dependence, as defined by
    DSM-IV-TR (with the exception of nicotine) within the last 6 months.
    13. Subject has a history of a seizure disorder (other than a single childhood febrile
    seizure occurring before the age of 3 years) or the presence of a serious tic disorder
    including Tourette’s syndrome.
    14. Subject has a known history or presence of structural cardiac abnormalities, serious
    heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically
    significant heart block), exercise-related cardiac events including syncope and pre
    syncope, or clinically significant bradycardia.
    15. Subject with orthostatic hypotension or a known history of controlled or uncontrolled
    hypertension.
    16. Current use of any prohibited medication or other medications, including herbal
    supplements, that affect BP or heart rate or that have CNS effects or affect cognitive
    performance, such as sedating antihistamines and decongestant sympathomimetics
    (inhaled bronchodilators are permitted) or a history of chronic use of sedating
    medications [i.e., antihistamines]) in violation of the protocol specified washout
    criteria at the Baseline Visit (Visit 2).
    17. Subject has a medical condition, other than ADHD, that requires treatment with
    medications that have central nervous system effects and/or affect performance.
    18. Subject is female and is pregnant or currently lactating.
    19. Subject failed screening or was previously enrolled in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are the long-term safety of SPD503 as follows:.
    • Occurrence of TEAEs from start of treatment to 3 days after cessation
    • Specific evaluation of BP and pulse at each applicable post baseline visit’
    • ECG results at each applicable post baseline visit’
    • C-SSRS at each applicable post baseline visit’
    • Effects on growth will be assessed at each applicable post baseline visit’ .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upto 2 years.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of the study are listed below:
    • The change from baseline in ADHD-RS-IV total score and the hyperactivity/impulsivity and inattention subscale scores at each of Visits 3-19. Baseline will be defined in 2 ways; firstly as the Baseline Visit from the antecedent study, and secondly as Visit 2 from this study.
    • The CGI-S at each of Visits 2-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    Upto 2 years.
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    This study has been designed to provide up to 2 years access to SPD503 for European children and adolescents who participated in Study SPD503-315 or SPD503-316 and provides the opportunity to assess the long-term safety and efficacy within this population.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Turkey
    Ukraine
    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
    Last subject last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 249
    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.1.1.5.1Number of subjects for this age range: 180
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-12. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the population age of trial subjects, adult/parental consent forms have been generated.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 249
    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)
    There are no planned additional care for subjects after the trial.
    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 Decision2012-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-15
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