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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2006-005512-27
    Sponsor's Protocol Code Number:B4Z-EW-LYDY
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-005512-27
    A.3Full title of the trial
    A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents.
    (ADHD-LIFE Study)
    A.3.2Name or abbreviated title of the trial where available
    (ADHD-LIFE Study)
    A.4.1Sponsor's protocol code numberB4Z-EW-LYDY
    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 and Company
    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 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 Yes
    D.2.1.1.1Trade name Strattera
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Limited
    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.3.1Product nameAtomoxetine Hydrochloride
    D.3.2Product code LY139603
    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 Hydrochloride
    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
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10003735
    E.1.2Term Attention deficit-hyperactivity disorder
    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 test the hypothesis that atomoxetine given at individually titrated doses for 6 months is superior to other early standard therapy in improving quality of life as measured by the mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF), in pharmacologically naïve children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • to compare atomoxetine with other early standard therapy at 4 months in patients with ADHD as measured by mean change in the achievement domain of the CHIP-CE PRF
    • to compare atomoxetine with other early standard therapy at 4 and 6 months in patients with ADHD as measured by change in the CHIP-CE PRF total score and domains (satisfaction, comfort, resilience and risk avoidance)
    • to compare atomoxetine with other early standard therapy at 4 months and 6 months in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
    • to compare atomoxetine with other early standard therapy at 4 months and 6 months in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) as measured by the ADHD-RS-IV Parent:Inv
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] Patients must be at least 6 years of age, but must not have reached their 17th birthday at Visit 1.
    [2] Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHD-RS-IV Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
    [3] Patients must be pharmacological naive at Visit 1. Pharmacological naive is defined as not having received more than seven consecutive days of any dose of pharmacotherapy for ADHD during the patient’s lifetime and having not received more than two consecutive days of any dose of pharmacotherapy for ADHD within 30 days before Visit 1.
    [4] Patients must be able to swallow capsules.
    [5] Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator’s judgment, to achieve a score of 80 on an IQ test). The administration of a formal IQ test is not an entry requirement for this study. Specific learning disabilities are not considered general impairments of intelligence.
    [6] Patients and parents/legal guardians have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
    [7] Patients and parents must be able to communicate adequately with the investigator and site personnel.
    [8] This inclusion criterion applies to females of child-bearing potential only.
    Test negative for pregnancy at the time of entry (Visit 1) based on a urine pregnancy test. If local law, an ERB and/or regulatory bodies have different requirements then these requirements take precedence.
    [9] Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an ICD.
    E.4Principal exclusion criteria
    [10] Patients who weigh less than 20 kg at study entry (Visit 1).
    [11] Patients who have a documented history of bipolar disorder, any history of psychosis or pervasive development disorder (autistic spectrum disorder). If the investigator believes that such a diagnosis has previously been made in error, he/she should contact Lilly and discuss the case history with the Lilly physician responsible for the study prior to allowing the patient to enter the study.
    [12] 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.
    [13] Patients at serious suicidal risk as assessed by the investigator. (This evaluation must include the items a, b, c, d and e of K- SADS-PL’s depression module, and there can not be a score of 3 in any of these items).
    [14] 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
    [15] Patients with significant prior or current medical conditions (for example human immunodeficiency virus (HIV+), surgically corrected congenital heart defects, or malignancy.
    [16] Patients who have a 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 that has sympathomimetic activity (for example, albuterol, inhalation aerosols, pseudoephedrine). Such medications can be taken on an occasional basis.
    [17] Patients with a history of hyperthyroidism or hypothyroidism will be excluded. However, patients who were previously diagnosed with hyperthyroidism or hypothyroidism, who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid will be allowed to participate in the study.
    [18] Patients with acute closed angle glaucoma.
    [19] Use of monoamine oxidase inhibitors (MAOIs) during the 2 weeks (14 days) prior to Visit 2.
    [20] 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 accuracy of historical diagnoses will be determined by the investigator.
    [21] Patients with cardiovascular disease, prolonged QT interval or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
    [22] Pregnant or breastfeeding females are excluded from the study.
    [23] Sexually active females who do not use a medically acceptable method of contraception are also excluded from the study. For this study, medically acceptable methods of contraception include barrier methods (condom or diaphragm with spermicidal agent) or oral contraception. The rhythm method (abstinence during predicted times of ovulation with unprotected intercourse at other times) or coitus interruptus prior to ejaculation by the male partner are not acceptable means of contraception.
    [24] Patients with a history of severe allergies to more than one class of medications or have had multiple adverse drug reactions.
    [25] Patients who at any time during the study period II are likely to begin a structured psychotherapy aimed at ADHD. Psychotherapy initiated at least 1 month prior to study participation is acceptable; however during study period II, after study participation has begun only supportive or educational therapy is permitted.
    [26] Patients who are taking any psychotropic medication as detailed in Attachment LYDY.5 on a regular basis must have a washout equal to a minimum of 5 half-lives of that medication prior to randomization. If the half-life of a medication is unknown, the Lilly physician should be consulted prior to entering the patient into the study.
    [27] Patients who are seeking ADHD treatment solely for improvement of school performance.
    [28] Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
    E.5 End points
    E.5.1Primary end point(s)
    6.1. Primary Outcome Variable, Quality of Life Measure
    The Child Health and Illness Profile (CHIP) is a validated, generic health-status survey developed to assess the overall health of children and adolescents. There is a parent-rated version for children (CHIP-CE PRF) and 2 self-rating versions, one for children and one for adolescents. The Child Edition (CHIP-CE CRF) is for ages 6 to 11 and the Adolescent Edition (CHIP-AE) is for ages 12 and older. The Parent Report Form for Children (CHIP-CE PRF) will be rated by the parents of both children and adolescents in this study. The parent-rated version has been selected as the primary outcome measure while the self-rated versions constitute secondary outcome measures in this study.
    Scores from the CHIP are reported at the domain level and as a profile-type. “Average”’ health on the CHIP domains is within 0.6 of a standard deviation of the mean of 50. That is, average/good health is in the range from 44 to 56 points (+/- 6 points, since the CHIP standard deviation is 10). A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The achievement domain describes the developmentally appropriate role functioning in school and with peers. It includes academic performance (5 items) and peer relations (5 items) sub domains.
    The CHIP instruments were developed and validated by Drs. Barbara Starfield, Anne Riley and their colleagues at the Johns Hopkins Bloomberg School of Public Health (Riley et al. 1998, Starfield et al. 2000, Riley et al. 2004a, Riley et al. 2004b, Rajmil et al. 2003). The CHIP-CE PRF has already been shown to be sensitive to changes in patients with ADHD (B4Z-BP-LYBS study).
    6.1.1. Child Health and Illness Profile – Child Edition – Parent Report Form (CHIP–CE PRF)
    The CHIP-CE, Parent Report Form (CHIP-CE PRF), will be rated by the parents of both children and adolescents at Visits 2, 4, 5, 6, 7, 10 and at early discontinuation The CHIP-CE PRF, is a parent rated assessment of a child’s health status and level of functioning. It consists of 76 items and takes approximately 20 minutes to complete. It is a validated and comprehensive measure of a child’s functioning and examines the following domains: Satisfaction, Comfort, Risk Avoidance, Resilience, and Achievement. The majority of items assess frequency of activities or feelings using a five-point response format (for example: 'How good is your child at making friends?' (1=never, 5=always).
    The total score will be calculated by summing the domain raw means and dividing by 5 (the number of domains).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 365
    F.4.2.2In the whole clinical trial 400
    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 Decision2007-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-03
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