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    Summary
    EudraCT Number:2008-001767-11
    Sponsor's Protocol Code Number:B4Z-EW-LYFJ
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-26
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2008-001767-11
    A.3Full title of the trial
    A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning compared with Fast Transitioning from a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
    A.3.2Name or abbreviated title of the trial where available
    LYFJ
    A.4.1Sponsor's protocol code numberB4Z-EW-LYFJ
    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 Limited
    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.2.5The 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.3.9.1CAS number 82248597
    D.3.9.3Other descriptive nameATOMOXETINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 40
    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/ADHD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 of the study is to compare the efficacy of 2 different switching approaches; at the end of the fast (Week 2) and slow (Week 10) transition from stimulants to atomoxetine as measured by Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator-Administered and Scored (ADHD-RS-IV Parent: Inv). The analysis will be based on the change from baseline to Weeks 2 and 10, respectively.
    E.2.2Secondary objectives of the trial
    Please see protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Parents of patients must have signed and dated the Informed consent document and assent should have been obtained from the patient (when appropriate)
    [2] Patients must be male or female outpatients who must be at least 6 years of age and must not have reached their 17th birthday by Visit 1.
    [3] Patients must meet the DSM-IV diagnostic criteria for ADHD (any subtype). For the purposes of this study, the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL (Section 4.1.1, Disease Diagnostic Criteria).
    [4] Patients must have laboratory results, including serum chemistries, hematology, and urinalysis (see Attachment LYFJ.2) showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) and no clinical information that, in the judgment of a physician, should preclude a patient’s participation at study entry. A patient with a clinically significant abnormal laboratory result 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 clinical research physician (CRP) monitoring the study should be consulted.
    [5] Patients must have an electrocardiogram (ECG) at Visit 1 with results available and reviewed prior to dispensing study drug at Visit 2. If an ECG shows an abnormality meeting one or more of the criteria in Protocol Attachment LYFJ.3, the patient must be excluded from the study. Patients with other abnormalities may be included at the discretion of the investigator; however, the Lilly CRP monitoring the study or designee must be notified.
    [6] Patients and parents (or legal representative) must have an educational level and degree of understanding sufficient to communicate suitably with the investigator and study coordinator.
    Atomoxetine B4Z-EW-LYFJ 18 March 2008
    Confidential
    Page 18
    [7] Patients must be of normal intelligence as assessed by the investigator (i.e., without a general impairment of intelligence and likely, in the investigator’s judgment, to achieve a score of ≥70 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.
    [8] Patients and parents (or legal representative) must be judged by the investigator to be reliable to keep appointments for clinic visits.
    [9] Patients must be able to swallow capsules.
    [10] Only patients with unsatisfactory symptom response to stimulant therapy such that the treating physician desires to change the patient’s therapy or patients experiencing AEs while on stimulant therapy are eligible for inclusion in the study.
    [11] For female patients 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.
    E.4Principal exclusion criteria
    [12] Patients who weigh less than 20 kg or more than 70 kg at study entry.
    [13] 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.
    [14] 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.
    [15] Patients determined by the investigator to be at serious suicidal risk.
    [16] Patients with a history of severe allergies to more than one class of medications or have had multiple adverse drug reactions.
    [17] Patients who have narrow angle glaucoma.
    Atomoxetine B4Z-EW-LYFJ 18 March 2008
    Confidential
    Page 19
    [18] 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.
    [19] Patients with acute or unstable medical conditions, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hypothyroidism or hyperthyroidism, acute systemic infection, renal insufficiency , gastroenterologic, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease should be excluded.
    [20] Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
    [21] Patients who have a medical condition that would markedly increase sympathetic nervous system activity (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudophedrine) having sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis.
    [22] Patients who at any time during the study are likely to need psychotropic medications apart from the drugs under study, including health-food supplements that in the investigator’s opinion have central nervous system (CNS) activity (for example, St. John’s Wort, melatonin).
    [23] Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 1.
    [24] Patients with hypertension which is clinically significant in the opinion of the investigator or who are currently taking an antihypertensive agent for blood pressure control.
    [25] Patients whose ECG at Screening shows an abnormality meeting one or more of the criteria in Protocol Attachment LYFJ.3
    [26] 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.
    [27] Pregnant or breastfeeding females are excluded from the study.
    Atomoxetine B4Z-EW-LYFJ 18 March 2008
    Confidential
    Page 20
    [28] 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.
    [29] Patients who at any time during the study are likely to begin a structured psychotherapy aimed at ADHD symptoms are excluded. Structured psychotherapy initiated at least 1 month prior to study participation is acceptable; however, after study participation started, only ad hoc supportive or educational therapy is permitted.
    [30] Patients who require immediate discontinuation of stimulants due to tolerability problems according to investigator’s evaluation.
    [31] Patients who are taking a stimulant at a dose higher than that specified by the stimulant’s product label.
    [32] Patients who are taking atypical stimulant regimes (combinations or multiple dosage forms) or stimulant dosage forms not readily amenable to dose reduction.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable in this study will be the change in the ADHD-RS-IV Parent:Inv (further on referred to as ADHD-RS) at the end of fast transition (Week 2; end of fast switching) and at the end of slow transition (Week 10; end of slow switching).
    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
    Switching from stimulants
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Slow transitioning compared with fast transitioning
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    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 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
    Study is in children aged over 6
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-14
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