Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-005701-32
    Sponsor's Protocol Code Number:B4Z-IT-LYDS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-005701-32
    A.3Full title of the trial
    An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder with or without comorbid conditions
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberB4Z-IT-LYDS
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorELI LILLY
    B.1.3.4CountryItaly
    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 Information not present in EudraCT
    D.2.1.1.1Trade name STRATTERA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAtomoxetine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Child or adolescent patients with Attention-Deficit/ Hyperactivity Disorder ADHD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10003736
    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 is to describe the efficacy of atomoxetine, given in an open-label manner, at flexible dosage up to 1.2 mg/kg/day, once daily for 12 weeks in improving psychosocial functioning of ADHD children and adolescents, in the presence of comorbid conditions. The effect on emotional and social well being of the child and the family will be evaluated by the mean change of the score of the domains Achievement of the Child Health and Illness Profile Child Edition CHIP-CE .
    E.2.2Secondary objectives of the trial
    To assess whether the effect of atomoxetine in improving ADHD core symptoms is influenced by the presence of comorbid conditions. To evaluate whether there are differences in improving symptoms of ADHD as measured by mean change CGI-ADHD-S. To assess whether atomoxetine has a different impact on the various aspects of life evaluated by the score of the other domains of the CHIP-CE. To investigate the effect of atomoxetine on internalizing and externalizing comorbid disorders as measured by PARS, CDRS-R and SNAP-IV. To obtain a parent evaluation of ADHD symptom and comorbid disorders symptoms measured by ASI-4 and CSI-4. To assess if atomoxetine works differently on problem behaviors related to ADHD in the school setting as measured by CTRS-R S. To assess whether the changes observed over 12 weeks are maintained over the longer term every three months . To evaluate the long-term tolerability and safety of atomoxetine as assessed by AEs elicited during open-ended questioning.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1 Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained. 2 Patients must meet DSM-IV diagnostic criteria for ADHD any subtype as defined in Section 4.3.1 Disease Diagnostic Criteria and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the SNAP-IV ADHD Subscale score refer to Protocol Attachment LYDS.2 at both Visit 1 and 2. Other comorbid conditions are allowed but the diagnosis of ADHD must be the patient s primary diagnosis. 3 Laboratory results, including serum chemistries, haematology, and urinalysis, must show no clinically significant abnormalities clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator . A patients with a significant abnormal laboratory results may enter the study if, after appropriate medical evaluation, the result does not indicate a serious medical condition that in the investigator s judgment would preclude participation. If there is any question about the appropriateness of participation or relevance of a particular finding, the Lilly physician monitoring the study should be consulted. In addition, there must be no clinical information that, in the judgment of a physician, should preclude a patient s participation at study entry. 4 An ECG must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material. 5 Patients must be of normal intelligence in the judgment of the investigator 61531;that is, without a general impairment of intelligence and likely, in the investigator s judgement, to achieve a score of 70 on an Intelligence Quotient IQ test 61533;. The administration of a formal QI test is not an entry requirement for the study. Specific learning disabilities are not considered general impairment of intelligence. 6 Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol. 7 Patients and parents must be able to communicate effectively with the investigator and study coordinator as well as be able to complete self reported scales used in the study. 8 Patients must be able to swallow capsules.
    E.4Principal exclusion criteria
    1 Patients who weigh less than 20 kg at study entry Visit 1 . 2 Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder. 3 Patients with a history of any seizure disorder other than febrile seizures or patients who have taken or are currently taking anticonvulsants for seizure control are not eligible to participate. 4 Patients at serious suicidal risk as assessed by the investigator. 5 Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions. 6 Patients with a history of alcohol or drug abuse within the past 3 months excessive or compulsive use as judged by the investigator , or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse. Patients who screen positive at study entry for drugs of abuse not prescribed by a physician are excluded from the study. 7 Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure. 8 Patients who have any medical condition that would increase sympathetic nervous system activity markedly for example, catecholamine-secreting neural tumor , or who are taking a medication on a daily basis for example, albuterol, inhalation aerosols, pseudoephedrine , that has sympathomimetic activity. Such medications can be taken on an as-needed basis. 9 Patients with current or past history of hypertension. For the purposes of this protocol, hypertension will be defined as average systolic or diastolic blood pressure, measured on at least 2 separate occasions, greater than or equal to the 95th percentile for age and sex defined by the National Heart and Lung Institute National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents 1996 . The adequacy of historical diagnoses will be determined by the investigator. 10 Patients with Narrow Angle Angle-Closure Glaucoma 11 Patients with uncontrolled hyperthyroidism or hypothyroidism. 12 Patients who, in the investigator s judgment, are likely to need psychotropic medications apart from the drug under the study, including health-food supplements that the investigator feels have central nervous system activity for example, St. John s Wort, melatonin . 13 Patients who at any time during the study are likely to begin a structured psychotherapy are excluded. 14 Use of monoamine oxidase inhibitors MAOIs during the 2 weeks 14 days prior to Visit 2. 15 Pregnant or breastfeeding females are excluded from the study. Sexually active females who do not use a medically acceptable method of contraception oral contraception or barrier methods as condom or diaphragm combined with spermicidal agent are also excluded from the study. 16 Patients who are directly affiliated with the conduct of this study, or are immediate family of someone directly affiliated with the conduct of this study that is, Lilly employees, investigators, site personnel, or their immediate families . Immediate family is defined as child or sibling, whether biological or legally adopted. 17 Patients who have participated in a prior clinical study of atomoxetine 18 Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study. 19 Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    E.5 End points
    E.5.1Primary end point(s)
    The effect on emotional and social well being of the child and the family will be evaluated by the mean change of the score of the domains Achievement of the Child Health and Illness Profile Child Edition CHIP-CE .
    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 Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months4
    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 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) Yes
    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 Information not present in EudraCT
    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 2006-03-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2006-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 07:11:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA