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    The EU Clinical Trials Register currently displays   43691   clinical trials with a EudraCT protocol, of which   7245   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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    EudraCT Number:2006-002253-71
    Sponsor's Protocol Code Number:LTE5894
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-002253-71
    A.3Full title of the trial
    A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron (350 mg twice a day) versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron (350 mg twice a day).
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberLTE5894
    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 SponsorSanofi-Aventis recherche & développement
    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.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 No
    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 nameNA
    D.3.2Product code SR58611A
    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 INNNA
    D.3.9.1CAS number 121524-09-2
    D.3.9.2Current sponsor codeSR58611A
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    General Anxiety 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
    To assess the efficacy of Amibegron 350 mg twice a day compared to placebo in the
    prevention of relapse of anxiety, in improved patients with generalized anxiety disorder (GAD), over a 24 to 52-week treatment period.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Amibegron on the secondary efficacy criteria. The secondary efficacy criteria will be the change from baseline (V7) of:
    • Clinical Global Impression (CGI) Severity of Illness score.
    • Hamilton Anxiety Rating Scale (HAM-A).

    To assess the safety and tolerability of Amibegron in patients with generalized anxiety disorder. The safety criteria will be the following:
    • Vital signs (including weight)
    • Spontaneously-reported adverse events
    • Clinical laboratories
    • Physician Withdrawal Checklist (PWC)
    • Montgomery and Asberg depression rating scale (MADRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For entry into the open phase:
    Patients suffering from generalized anxiety disorder, according to Diagnostic and
    Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the
    Mini International Neuropsychiatric Interview (MINI) (7) plus GAD module with a total
    score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ≥ 20 at V1(D-4) and V2

    For entry into the double-blind randomized phase:
    Improved patients with HAM-A score < 11 at V7 (W12).
    E.4Principal exclusion criteria
    Related to study methodology
    1. Inpatients.
    2. Patients < legal age of majority.
    3. Patients unable to give voluntarily their written informed consent to participate in the whole study or to comply with the protocol and follow written and verbal instructions.
    4. Patients with a diagnosis of Major Depressive Disorder as defined by DSM IV-TR
    within 6 months of screening.
    5. Patients with a Montgomery and Asberg Depression Rating Scale (MADRS) (9) total
    score > 18 at screening (Visit 1, Day -4) or baseline (Visit 2, Day -1).
    6. Patients at immediate risk for suicidal behavior based on an unstructured clinical
    interview; or who have, before first study drug intake [at either the screening (V1) or
    baseline (V2) visits]:
    • A score of > 5 on the suicidal thoughts item of the MADRS
    • Or, a current suicide risk score ≥10 from module C of the (MINI).
    7. Patients with other current (within 6 months) anxiety disorder according to the MINI of:
    • Panic disorder,
    • Agoraphobia,
    • Social phobia,
    • Obsessive compulsive disorder (OCD),
    • Post-traumatic stress disorder (PTSD).
    8. Patients with a lifetime history according to the MINI of:
    • Bipolar disorder,
    • Psychotic disorder,
    • Antisocial personality disorder.
    9. Patients with a current history according to the MINI of:
    • Anorexia nervosa or bulimia nervosa in the past 6 months
    • Alcohol dependence or abuse or substance dependence or abuse in the past 12
    months, except nicotine or caffeine dependence.
    10. Patients who have used the following medications prior to screening:
    • Any continuous use of anxiolytic (e.g., benzodiazepines, buspirone) or hypnotic
    (e.g., zolpidem, zaleplon) within 2 weeks. Chronic means more than 2 days per
    • Any antipsychotic within 3 months,
    • Any antidepressant within 4 weeks,
    • Any mood-stabilizer (lithium, anticonvulsants) within 4 weeks.
    11. Treatment with electroconvulsive therapy (ECT) or rapid Transcranial Magnetic
    Stimulation (r TMS) within 3 months prior to screening.
    12. Patients who have initiated, stopped, or changed the frequency or nature of
    psychotherapy within 3 months prior to screening.
    13. Patients with severe or unstable concomitant medical conditions (cardiovascular,
    neurological, gastrointestinal, hepatic, renal, endocrinologic, rhumatologic) according
    to the investigator's judgment that would impact the assessment of the study drug.
    14. History of seizures other than a single childhood febrile seizure.
    15. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST > 2 times upper limit of normal range (ULN), hemoglobin < 12g / 100ml for
    male and < 11g / 100ml for female, neutrophils < 1500/mm3, platelets < 100 000/mm3, creatinine ≥ 150 µmol/l.
    16. Patients with clinically significant ECG findings or positive results on the urine drug screen at screening.
    17. Patients who have taken an investigational drug in the last 3 months prior to screening.
    18. Any patient who has previously participated in a Amibegron protocol.
    19. Females of childbearing potential with a positive β-HCG pregnancy test at screening, or not using an effective method of birth control during the entire study period (i.e. birth control pill, intrauterine device, hormonal injection, sterilization or barrier method plus spermicide) and females pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by any one of the following criteria:
    • HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out, or
    • Any drop-out for lack of efficacy (according to investigator’s decision based on his/her knowledge of the patient), or
    • Prescription/use of alternative or additional treatments (pharmacological or nonpharmacological) for relief of psychiatric symptoms.
    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 No
    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. 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 Yes
    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 Yes
    E. trial design description
    Randomized withdrawal
    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 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
    The overall end of study is defined by the date of the last follow-up visit of the last
    randomized patient to complete 24 weeks of double-blind treatment without experiencing relapse. At that time, the study will be stopped and the patients under double-blind treatment will have to stop their treatment at the next planned visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2006-08-23. Yes
    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 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 240
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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