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    Summary
    EudraCT Number:2004-000751-42
    Sponsor's Protocol Code Number:D1441C00150
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-000751-42
    A.3Full title of the trial
    A 26-week, International, Multicenter, Open-label Phase IIIb
    Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™)
    Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and
    Adolescents with Bipolar I Disorder and Adolescents with Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    ANCHOR 150
    A.4.1Sponsor's protocol code numberD1441C00150
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Seroquel 25 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSEROQUEL
    D.3.2Product code ZD5077
    D.3.4Pharmaceutical form Tablet
    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 INNQuetiapine fumarate
    D.3.9.1CAS number 11974-72-2
    D.3.9.2Current sponsor codeZD5077
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Seroquel 100 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSEROQUEL
    D.3.2Product code ZD5077
    D.3.4Pharmaceutical form Tablet
    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 INNQuetiapine fumarate
    D.3.9.1CAS number 11974-72-2
    D.3.9.2Current sponsor codeZD5077
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    SCHIZOPHRENIA or BIPOLAR I DISORDER
    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 of this study is to assess the safety and tolerability of quetiapine in children and adolescent patients with Bipolar I disorder and in adolescents with schizophrenia who are treated with doses of 400 mg/day to 800 mg/day for up to 26 weeks. The primary objective will be assessed by:
    - the incidence and nature of overall AEs
    - the rate of patient withdrawal due to AEs
    - the changes from the open-label baseline to Week 26 in clinical laboratory test results, vital signs, weight, BMI, ECG results, and physical examination
    findings. The OL baseline will be defined as the final assessment in the
    preceding double-blind study (D1441C00149 or D1441C00112).
    - the changes from OL baseline to Week 26 in the Simpson-Angus Scale total score, the Barnes Akathisia Rating Scale global score, and the Abnormal Involuntary Movement Scale total score
    - the proportion of patients treated with anticholinergic medication for emergent
    EPS
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:
    1. to evaluate the growth and development of patients receiving long-term treatment with quetiapine at doses of 400 mg/day to 800 mg/day, as assessed by change from OL baseline to Week 26 in the Tanner Stage, initiation of or changes in menses for female patients, and changes from OL baseline to Week 26 in weight and BMI
    2. to evaluate the level of functioning in patients receiving long-term treatment with
    quetiapine at doses of 400 mg/day to 800 mg/day, as assessed by changes from OL
    baseline to Week 26 in the Children’s Global Assessment Scale (CGAS; Shaffer et al
    1983) score
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of written informed consent by one or both parents or by legal guardian
    prior to any study procedure
    2. Provision of written assent by the patient prior to any study procedure
    3. Prior participation in Study D1441C00149 or Study D1441C00112 for > or = 14 days
    4. Male or female; aged 13 to 17 years at randomization of Study D1441C00112 or
    aged 10 to 17 years at baseline of Study D1441C00149. Patients who become
    18 years of age after entering Study D1441C00112 or D1441C00149 will be
    permitted to enter this OL study.
    5. If female and of childbearing potential, must be using a reliable method of
    contraception. Reliable methods may include abstinence, hormonal contraceptives
    (eg, oral contraceptive or long-term injectable or implantable hormonal
    contraceptive), double-barrier methods (eg, condom and diaphragm, condom and
    foam, condom and sponge), intrauterine devices, and tubal ligation.
    6. All female patients will need to have the absence of pregnancy confirmed by a
    negative serum beta hCG before OL baseline
    7. DSM-IV criteria for schizophrenia or bipolar I disorder, confirmed by the
    K-SADS-PL at entry into the preceding double-blind Study D1441C00149 or Study
    D1441C00112
    8. Willingness to agree not to harm self
    9. Have a parent or legal guardian who will accompany the patient at each scheduled
    study visit, can provide reliable information, and can be responsible for receiving
    and dispensing study medication
    10. Willingness to adhere to the schedule of assessments
    E.4Principal exclusion criteria
    1. DSM-IV Axis I diagnoses of Schizophreniform Disorder, Schizoaffective Disorder,
    Psychotic Disorder Not Otherwise Specified (NOS), Bipolar II Disorder, Bipolar
    Disorder Not Otherwise Specified (NOS)
    2. An interval greater than 7 days between the last double-blind study visit (OL
    baseline) and Day 1
    3. Premorbid intelligence quotient (IQ) <70 or diagnosis of mental retardation
    4. Psychosis judged to be the direct physiological consequence of a medical condition
    or treatment. These conditions include degenerative neurological conditions (eg,
    Parkinson’s disease, Huntington’s disease), cerebrovascular disease (eg, stroke),
    metabolic conditions (eg, vitamin B12 deficiency), autoimmune conditions (eg,
    systemic lupus erythematosus), viral or other infections (eg, hepatitis,
    mononucleosis, human immunodeficiency), and cancers.
    5. Psychosis judged to be the direct physiological effect (eg, intoxication, withdrawal)
    of an abused medication or substance
    6. History of any serious suicide attempt that required medical intervention; or current
    suicidal risk that cannot be safely managed as determined by the clinical judgment
    of the investigator
    7. Serious homicidal risk or homicidal behavior within the past 3 months that resulted
    in adjudication
    8. Known intolerance for or lack of response to quetiapine, as judged by the
    investigator
    9. Contraindications as detailed in country-specific prescribing information for
    quetiapine
    10. For female patients, pregnancy or lactation
    11. Substance abuse or dependence including alcohol (except for caffeine or nicotine
    dependence), as defined in DSM-IV, within 1 month prior to screening
    12. Use of depot antipsychotics, eg, haloperidol decanoate, fluphenazine decanoate or risperidone microspheres, within 1 dosing interval of the start of open-label
    treatment
    13. Electronconvulsive therapy (ECT) within 30 days before enrollment
    14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ketconazole,
    itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir,
    nelfinavir, ritonavir, and sequinavir) in the 14 days preceding enrollment
    15. Use of potent CYP 3A4 inducers (eg, phenytoin, carbamazepine, barbiturates,
    rifampin, glucocorticoids, Saint John’s Wort) in the 14 days preceding enrollment
    16. Thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range at OL baseline
    17. Laboratory test results outside the reference range at OL baseline and considered by the investigator to be clinically significant
    18. Baseline QTc interval (Fridericia formula; Puddu et al 1988) > or = 450 milliseconds at OL baseline
    19. Renal, cardiovascular, hepatic, hematologic, endocrinologic, ophthalmologic, or
    other disease or clinical finding that is unstable or that in the opinion of the
    investigator would be negatively affected by study medication or that would affect
    study medication
    20. Unstable Diabetes Mellitus (DM) with an OL baseline HgbA1c > or = 8.5
    21. Patients admitted to a hospital for treatment of diabetes or diabetes related illness in past 12 weeks
    22. Not under the care of a physician responsible for the patient’s DM care
    23. DM clinically unstable in the opinion of the physician responsible for the patient’s
    diabetes management at the time of OL baseline
    24. The physician responsible for the patient’s DM care has not approved the patient’s participation in the study
    25. The patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to OL baseline. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
    26. A patient taken insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
    27. If the patient’s CBC with WBC differential shows an ANC < 1.0 x 10 9 /L, repeat the test within 24 hours. If it remains < 1.0 x 10 9 /L, the patient will be excluded.
    28. Medical condition that would affect absorption, distribution, metabolism, or
    excretion of study medication
    29. History of seizure disorder, except febrile convulsions
    30. Use of experimental drug outside of a quetiapine study within 30 days of enrollment
    31. Significant medical illness which could prevent patient from completing open-label
    treatment
    32. Previous participation in this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary study variables are as follows:
    - the incidence and nature of overall AEs from OL baseline to Week 26
    - the rate of patient withdrawal due to AEs
    - the changes from OL baseline to Week 26 in clinical laboratory test results (eg,
    prolactin concentration), vital signs, weight, BMI, ECG results, and physical
    examination findings
    - the changes from OL baseline to Week 26 in the SAS, BARS, AIMS scores
    - the proportion of patients treated with anticholinergic medication for emergent EPS
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 No
    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) 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 Yes
    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 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
    The end of the study will be defined as the date on which database lock occurs
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 2006-02-09. 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.3.3.6.1Details of subjects incapable of giving consent
    Assent form provided to patients and informed consent form provided to parent or legal guardian.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children and adolescents (aged 10-17 years)
    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 50
    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)
    Patients who complete Study D1441C00150 will continue treatment according to standard local clinical practice based on the investigator’s judgment.
    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 Decision2006-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-11
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