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    Summary
    EudraCT Number:2004-003941-42
    Sponsor's Protocol Code Number:B4Z-SO-LY15
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-003941-42
    A.3Full title of the trial
    A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and Adolescents
    A.4.1Sponsor's protocol code numberB4Z-SO-LY15
    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 Sweden AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing 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 and Company United States
    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 nameatomoxetine
    D.3.2Product code LY139603
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    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) is a common psychiatric disorder that has its onset in childhood, and that is estimated to occur in 3% to 6% of school-age children. ADHD is characterized by levels of increased motor activity, impulsiveness, distractibility, restlessness and inattention that is maldaptive and inconsistent with the child´s developmental level.
    MedDRA Classification
    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 and psychoeducation given for 10 weeks is superior to placebo and psychoeducation in improving overall functioning of patients, age 7-15 years, with Attention-Deficit/Hyperactivity Disorder (ADHD), as measured by the mean change in the total score of the Child Health and Illness Profile-Child Edition-Parent form (CHIP-CE-Parent form) domain Achievement (containing two subdomains: Academic performance och Peer relations).
    E.2.2Secondary objectives of the trial
    Secondary aims with the study is to compare atomoxetine and psychoeducation with placebo and psychoeducation at 10 weeks of double-blind treatment, measured with the remaining four CHIP-CE domains (Satisfaction, Comfort, Risk Avoidance, Resilience); total CHIP-CE score; "Jag tycker jag är" (I think I am), a Swedish self-assessment scale regarding self image, Family Burden of Illness (FBIM), a simple questionnaire on the impact of the child's illness on family life and functioning; and Appraisal of Stress in Family Rearing (ASCR), a questionnaire regarding the degree of emotional stress that parents' experience in their rearing of their child. In a separate health outcomes section the direct and indirect costs for the family and for the society will be explored, before and after treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1] Meet the criteria for ADHD of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IVä) as well as severity criteria. Diagnosis is assessed by the investigator’s clinical evaluation as well as administration of the K-SADS-PL structured interview (Kaufman et al. 1997; see Section 3.1 Study Period I, and Attachment LY15.1, Schedule of Events).
    [2] Meet a symptom severity threshold of 1.5 standard deviations above age and sex norms for their diagnostic subtype on the ADHDRS-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) (Attachment LY15.7). This severity threshold must be met at Visit 1 and maintained at Visit 2.
    [3] Be at least 7 years of age, but not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
    [4] For female subjects of child-bearing potential only, test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control (for example, oral contraceptives, levonorgestrel implant, or a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study.
    [5] Be able to swallow capsules.
    [6] 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 ³70 on an intelligence quotient [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.
    [7] For patients and parents/legal guardians, be judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
    [8] For patients and parents, be able to communicate effectively with the investigator and site personnel.
    E.4Principal exclusion criteria
    [9] Weigh less than 20 kg at study entry (Visit 1). If a patient’s weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
    [10] Have a documented history of Bipolar Disorder or any history of psychosis or pervasive development disorder (autistic spectrum disorder).
    [11] Are pregnant or breastfeeding.
    [12] Have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are taking) anticonvulsants for seizure control are not eligible to participate.
    [13] Are at serious suicidal risk as assessed by the investigator.
    [14] Are taking any psychotropic medication on a regular basis, including health-food supplements that the investigator feels may have central nervous system activity (for example, St. John’s Wort, Ephedra, melatonin, Omega-3), must have a washout equal to a minimum of 5 half-lives of that medication prior to starting atomoxetine treatment. If the half-life of a medication is unknown, the Lilly clinical research physician should be consulted prior to entering the patient into the study.
    [15] Have been treated previously for ADHD with psychostimulants such as Methylphenidate or Ritalin.
    [16] Have 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 the investigator considers indicative of abuse.
    [17] Have significant prior or current medical conditions (for example, human immunodeficiency virus [HIV], surgically corrected congenital heart defects, or malignancy).
    [18] Have any medical condition that would markedly increase sympathetic nervous system activity (for example, catecholamine-secreting neural tumour).
    [19] Have a thyroid-stimulating hormone (TSH) level consistent with hyperthyroidism or hypothyroidism will be excluded. However, patients 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.
    [20] Have acute closed-angle glaucoma.
    [21] Are taking a medication that has sympathomimetic activity (e.g., albuterol, inhalation aerosols, pseudoephedrine). However, such medications can be taken on an as-needed basis.
    [22] Use monoamine oxidase inhibitors (MAOIs) during the 2 weeks (14 days) prior to Visit 2.
    [23] Have current or past history of hypertension. For the purposes of this protocol, hypertension is 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 in Wilton (1983). The adequacy of historical diagnoses will be determined by the investigator.
    [24] Are receiving formal structured individual or family psychotherapy during Study Period I and Study Period II. Patients may enter the study if such treatment has been completed before entry into the trial. Formal structured individual or family therapy is allowed during Study Period III.
    [25] Have a poor understanding of the Swedish language that in the opinion of the investigator renders the application of rating scales inappropriate.
    [26] Are, in the opinion of the investigator, unsuitable in any other way to participate in this study, such as children whose symptoms are so severe, they require immediate therapy.
    [27] Have previously completed or withdrawn from this study or any other study investigating atomoxetine.
    [28] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [29] Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [30] 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 primary efficacy variable is the mean score on the Achievement domain of the CHIP-CE. The primary efficacy analysis will be a repeated measures mixed model analysis. The dependent variable will be evaluated at Visits 2 and 7. The model will contain terms for baseline score, treatment, site, visit, and treatment-by-visit interaction. Baseline is defined as scores obtained at Visit 2. The analysis will include CDRS-R as a covariate, since earlier findings have reported possible improvement of the CDRS-R score as a result of the treatment, which potentially may influence the primary efficacy variable.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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.8.5The 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
    End of study (trial) is the date of the last visit or last scheduled procedure shown in the Study Schedule of the last subject active in 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 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 No
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Cildren under 18 years old
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 100
    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)
    Not applicable
    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 Decision2005-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-21
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