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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2005-005054-46
    Sponsor's Protocol Code Number:D1448C00011
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-005054-46
    A.3Full title of the trial
    An International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-controlled Study of the Efficacy and Safety of Sustained-release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER Study)
    A.3.2Name or abbreviated title of the trial where available
    Silver Study
    A.4.1Sponsor's protocol code numberD1448C00011
    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.2.5The 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 SR
    D.3.2Product code ZD5077
    D.3.4Pharmaceutical form Film-coated 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 Sustained Release
    D.3.9.1CAS number 111974-72-2
    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 number50
    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 RoleComparator
    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 Paxil
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmilthKline
    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 nameSeroxat
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNParoxetine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    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 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
    Generalised Anxiety Disorder (GAD)
    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 evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).
    E.2.2Secondary objectives of the trial
    1.The effect of quetiapine SR on the health-related quality of life in patients with GAD.
    2.The early efficacy of quetiapine SR in the treatment of anxiety symptoms in patients with GAD.
    3.The efficacy of quetiapine SR in the treatment of anxiety symptoms in patients with GAD.
    4.The efficacy of quetiapine SR in the treatment of anxiety symptoms in patients with GAD.
    5.The efficacy of quetiapine SR by evaluating the response rate in the treatment of anxiety symptoms in patients with GAD.
    6.The efficacy of quetiapine SR by evaluating the remission rate in the treatment of anxiety symptoms in patients with GAD.
    7.The efficacy of quetiapine SR in the treatment of depressive symptoms in patients with GAD.
    8.The efficacy of quetiapine SR in improving sleep quality in patients with GAD.
    9.To evaluate if quetiapine SR improves patient satisfaction in patients with GAD.
    10.The safety and tolerability of quetiapine SR in patients with GAD.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Provision of informed consent before initiation of any study related procedures.
    2.Male or female aged 18 to 65 years, inclusive.
    3.A documented clinical diagnosis of generalized anxiety disorder (GAD) according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria 300.02 as assessed by the MINI (Mini-International Neuropsychiatric Interview).
    4.HAM-A administered by use of the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) total score ≥20 with Item 1 (anxious mood) and Item 2 (tension) scores ≥2 at both enrollment and randomization.
    5.A CGI-S score ≥4 at both enrollment and randomization.
    6.Absence of current episode of major depression, documented by a MADRS total score ≤16 at either enrollment or randomization.
    7.Female patients must have a negative serum pregnancy test at enrollment and be willing to use a reliable method of birth control.
    8.Be able to understand and comply with the requirements of the study.
    9.Be able to read and write and be able to understand and use IVRS.
    10.Outpatient status at enrollment and randomization, i.e, patient is not hospitalized.
    E.4Principal exclusion criteria
    1.Patients with a current DSM-IV Axis I disorder other than generalized anxiety disorder or simple phobia within 6 months of enrollment.
    2.The presence or history of schizophrenia and other psychotic disorders according to DSM-IV.
    3.The presence of any DSM-IV Axis II disorder that is likely to interfere with the patient’s ability to participate in the study as judged by the investigator.
    4.Patients who, in the investigator’s judgment, pose a current serious suicidal or homicidal risk or have made a suicide attempt or patients who have a MADRS Item 10 score ≥4.
    5.Evidence of clinically relevant disease, eg, renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator.
    6.A clinical finding that is unstable (e.g. hypertension, poorly controlled diabetes, unstable angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
    7.Conditions that could affect absorption and metabolism of study medication (e.g. malabsorption syndrome, liver disease) as judged by the investigator.
    8.History of seizure disorder, except febrile convulsions.
    9.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
    10.Current or past diagnosis of stroke or Transient Ischemic Attack (TIA).
    11.Pregnancy or lactation.
    12.Substance or alcohol abuse or dependence.
    13.Use of antipsychotic medication within 28 days prior to randomization.
    14.Receipt of electroconvulsive therapy (ECT) within 28 days prior to randomization.
    15.Patients who in the investigators opinion will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomization.
    16.Use of benzodiazepines, antidepressants, MAO inhibitors and mood stabilizers within 14 days prior to randomization.
    17.Use of benzodiazepines, maximum allowable dose of 10 mg equivalent of diazepam per day, more than 3 times per week in the period 14 to 28 days prior to randomization.
    18.Use of hypnotics, maximum allowable single dose of 20 mg zolpidem tartrate, 1 gram chloral hydrate, 20 mg zaleplon, or 7.5 mg zolpiclone, at bedtime more than 3 times per week in the 28 days prior to randomization.
    19.Administration of a depot antipsychotic medication within 2 dosing intervals prior to randomization.
    20.Use of potent cytochrome P450 3A4 inducers (eg, barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, rifabutin, thioridazine, and St. John’s Wort) in the 14 days preceding randomization.
    21.Use of potent cytochrome P450 3A4 inhibitors in the 14 days preceding randomization.
    22.A patient with diabetes mellitus.
    23.Clinically significant deviation from the reference range in clinical laboratory test results at enrollment, as judged by the investigator.
    24.If the patient’s CBC with WBC differential shows an ANC ≤1.5 x 109/L.
    25.A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrollment, whether or not the patient is being treated for hypothyroidism.
    26.ECG results considered clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG.
    27.AST, ALT levels > 3 times the upper limit of normal.
    28.Treatment with quetiapine or paroxetine in the 6 months prior to randomization.
    29.Known history of intolerance or hypersensitivity to quetiapine, paroxetine, or to any other component in the tablets.
    30.Known lack of response to quetiapine in the treatment of anxiety in a dosage of at least 50 mg for 4 weeks at any time, as judged by the investigator.
    31.Known lack of response to paroxetine in the treatment of anxiety in a dosage of at least 20 mg for 4 weeks, as judged by the investigator.
    32.Contraindications as detailed in the country-specific prescribing information for quetiapine.
    33.Use of any other investigational compound, or participation in another clinical study or compassionate use program within 28 days prior to enrollment.
    34.Involvement in the planning and conduct of the study (applies to AZ staff, staff at the investigational site, and third-party vendors).
    35.Previous enrollment or randomization to treatment in the following quetiapine GAD studies; D1448C00009;D1448C00011;D1448C00012.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) by measuring the change from randomization in the Hamilton Anxiety Scale (HAM-A) total score at Day 57.
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paroxetine
    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
    End of study is defined as database lock, which is the time point after which no patient will be exposed to study related activities.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    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 2006-05-12. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 495
    F.4.2.2In the whole clinical trial 805
    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 Decision2006-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-05-01
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