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    Summary
    EudraCT Number:2004-000750-22
    Sponsor's Protocol Code Number:D1441C00112
    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:2006-02-03
    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 number2004-000750-22
    A.3Full title of the trial
    A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Immediate-release Tablets in Daily Doses of 400 mg and 800 mg Compared with Placebo in the Treatment of Adolescents with Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    ANCHOR 112
    A.4.1Sponsor's protocol code numberD1441C00112
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    SCHIZOPHRENIA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    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 compare the efficacy of 2 doses of quetiapine
    (400 mg/day and 800 mg/day) with that of placebo in the treatment of schizophrenia in adolescent patients as assessed by the change from baseline to Day 42 in the PANSS total score (primary outcome variable). The primary hypotheses are as follows:
    1. Quetiapine 400 mg/day is superior to placebo in reducing PANSS total score at Day 42 compared with baseline.
    2. Quetiapine 800 mg/day is superior to placebo in reducing PANSS total score at Day 42 compared with baseline.
    E.2.2Secondary objectives of the trial
    1. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with
    the effect of placebo on a broad range of schizophrenia symptoms
    2. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with
    the effect of placebo on level of functioning, as assessed by the change from
    baseline to Day 42 in the Children’s Global Assessment Scale (CGAS; Shaffer et al
    1983) total score
    3. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with
    the effect of placebo on aggression and hostility, as assessed by the changes from
    baseline to Days 7, 14, and 42 in the sum of the scores for PANSS items S1, S2, and
    S3
    4. to evaluate the safety and tolerability of quetiapine compared with placebo in the
    treatment of schizophrenia in adolescent patients
    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. Male or female, aged 13 to 17 years at randomization, hospitalized or outpatient
    4. 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.
    5. All female patients will need to have the absence of pregnancy confirmed by a
    negative b-hCG before randomization
    6. DSM-IV criteria for schizophrenia confirmed by the K-SADS-PL
    7. The SCQ will be administered to assess for Pervasive Development Disorders.
    Patients with an SCQ score of > or = 15 and who otherwise meet entrance criteria must have a documented history of delusions or hallucinations.
    8. Patients with a secondary diagnosis of depression may continue treatment with an
    antidepressant if clinically advised by the investigator, providing the antidepressant
    is permitted by the protocol and the dose has been stable for > or = 30
    days preceding randomization
    9. PANSS score of > or = 60 and a score of 4 or greater on at least 1 of the following items;
    delusions (P1), conceptual disorganizations (P2), or hallucinations (P3) at both
    screening and randomization (Day 1)
    10. Willingness to agree not to harm self
    11. 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
    12. Willingness to adhere to the schedule of assessments
    E.4Principal exclusion criteria
    1. Secondary DSM-IV Axis I diagnoses of Bipolar Disorders including Cyclothymia,
    Schizophreniform Disorder, Schizoaffective Disorder, Psychotic Disorder Not
    Otherwise Specified (NOS), and acute (<3 months) Posttraumatic Stress Disorder
    (PTSD).
    2. Premorbid intelligence quotient (IQ) <70 or diagnosis of mental retardation
    3. 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.
    4. Psychosis judged to be the direct physiological effect (eg, intoxication, withdrawal)
    of an abused medication or substance
    5. 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
    6. Serious homicidal risk or homicidal behaviors within the past 3 months that resulted
    in adjudication
    7. Known intolerance for or lack of response to quetiapine, as judged by the
    investigator
    8. Contraindications as detailed in country-specific prescribing information for
    quetiapine
    9. For female patients, pregnancy or lactation
    10. Substance abuse or dependence (Appendix D) including alcohol (except for caffeine
    or nicotine dependence), as defined in DSM-IV, within 1 month prior to screening
    11. Inability to discontinue psychoactive medications (see Section 3.4.4.1, Table 4)
    prior to randomization
    12. Use of haloperidol decanoate, fluphenazine decanoate or risperidone microspheres
    within 1 dosing interval prior to randomization
    13. Electroconvulsive therapy (ECT) within 30 days prior to screening
    14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ketoconazole,
    itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir,
    nelfinavir, ritonavir, and saquinavir) in the 14 days preceding randomization
    15. Use of potent CYP 3A4 inducers (eg, phenytoin, carbamazepine, barbiturates,
    rifampin, glucocorticoids, Saint John’s Wort) in the 14 days preceding
    randomization
    16. Thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range
    17. Laboratory test results outside the reference range and considered by the
    investigator to be clinically significant
    18. Baseline QTc interval (Fridericia formula; Puddu et al 1988) > or = 450 milliseconds at 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 a baseline Glycosylated Hemoglobin
    (HbA1c) Ÿ8.5
    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 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 randomization. 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 within 30 days of randomization (Day 1)
    31. Previous participation in this study
    32. Significant medical illness which could prevent patient from completing
    double-blind treatment
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Day 42 in the PANSS total
    score
    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 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 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 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 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 double-blind 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 months3
    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 months2
    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) No
    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 2006-02-03. 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
    Adolescents (13-17 years)
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 198
    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 D1441C00112 will have the option to continue study treatment with quetiapine in the open-label safety study (Study D1441C00150). If a patient is unable or unwilling to enter into Study D1441C00150 upon completion of Study D1441C00112, treatment will be continued 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 Opinion2006-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-28
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