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    Summary
    EudraCT Number:2007-004740-79
    Sponsor's Protocol Code Number:D1443L00039
    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:2008-01-11
    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 number2007-004740-79
    A.3Full title of the trial
    A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated with Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting
    A.3.2Name or abbreviated title of the trial where available
    RECOVER
    A.4.1Sponsor's protocol code numberD1443L00039
    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 GmbH
    B.1.3.4CountryGermany
    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 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 nameSeroquel XR
    D.3.4Pharmaceutical form Prolonged-release 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
    D.3.9.1CAS number 111974697
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    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 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 nameSeroquel XR
    D.3.4Pharmaceutical form Prolonged-release 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
    D.3.9.1CAS number 111974697
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Risperdal
    D.2.1.1.2Name of the Marketing Authorisation holderJansen-Cilag
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRisperdal
    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 INNRISPERIDONE
    D.3.9.1CAS number 106266062
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Risperdal
    D.2.1.1.2Name of the Marketing Authorisation holderJansen-Cilag
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRisperdal
    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 INNRISPERIDONE
    D.3.9.1CAS number 106266062
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 5
    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 Yes
    D.2.1.1.1Trade name Risperdal
    D.2.1.1.2Name of the Marketing Authorisation holderJansen-Cilag
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRisperdal
    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 INNRISPERIDONE
    D.3.9.1CAS number 106266062
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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 demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K.
    E.2.2Secondary objectives of the trial
    A secondary objective of particular interest is to demonstrate the non-inferiority of quietapine XR to risperidone assessed at month 12 by evaluating the change from baseline in SWN-K mean total score.

    Other secondary objectives of the study are to evaluate in both treatment groups the following:
    1. Severity of patient symptoms using the CGI-SCH scale.
    2. Subjective changes using the SWN-K scale.
    3. Remission rate during the study using the SWN-K scales.
    4. Depressive symptoms changes using the CDSS.
    5. Quality of life changes using the EQ-5D.
    6. Relapse rate in terms of symptoms and/or re-hospitalization.
    7. Resource utilization for health economics.
    8. Safety and tolerability.
    9. Treatment adherence.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimento Informado assinado. Doentes incapazes de assinar o Consentimento Informado podem ser incluídos no estudo desde que o representante legal do doente assine o Consentimento de acordo com a Legislação Local.
    2. Homens ou mulheres em regime ambulatório com idades entre os 18 e os 65 anos.
    3. Doentes tratados para esquizofrenia (códigos DSM-IV-TR 295.10, 295.20, 295.30, 295.60, 295.90), doença esquizoafectiva (código DSM-IV-TR 295.70) ou doença esquizofreniforme (código DSM-IV-TR 295.40). Doentes com sintomas depressivos co-mórbidos podem ser incluídos.
    4. Doentes com um primeiro episódio dos acima mencionados (Item 3) ou doentes que requeiram alteração da terapêutica por razões clínicas (efectividade, tolerabilidade, adesão ao tratamento, preferência do doente), isto é mudança de antipsicóticos típicos para atípicos, mudança de outros antipsicóticos atípicos, excluindo doentes tratados com risperidona ou quetiapina na altura da randomização.
    5. Mulheres em idade fértil têm de ter, no dia da inclusão, um teste de gravidez na urina negativo que será confirmado por um teste no sangue, e terão de estar dispostas a utilizar métodos fiáveis de contracepção, ou seja duplo método barreira, contraceptivos orais, implantes, contracepção dérmica, contracepção injectável de longa duração, dispositivo intra-uterino ou laqueação de trompas durantes o estudo, segundo critério do investigador.
    6. Estar apto a compreender e a aderir aos procedimentos do estudo segundo avaliação do investigador.
    E.4Principal exclusion criteria
    1.Doentes com valores totais da escala SWN-K superiores a 75.
    2. Doentes previamente tratados com risperidona ou quetiapina podem ser incluídos, desde que a alteração da terapêutica não tenha sido motivada pela falta de tolerabilidade e eficácia e a última dose tenha ocorrido há, pelo menos, 3 meses à data da inclusão.
    3.Doentes medicados com antidepressivos ou estabilizadores do humor que não sofreram alteração da dose pelo menos nas 2 semanas anteriores à randomização.
    4.Doentes com Diabetes Mellitus (DM) conhecida preenchendo um dos seguintes critérios:· História conhecida de DM instável definida como hemoglobina glicosilada (HbA1c) > 8.5%.· Admissão hospitalar para tratamento da DM ou doença relacionada com a DM nos últimos 12 meses.· Sem acompanhamento médico para a DM.· O médico responsável pelo tratamento da DM considera que o doente não está controlado.· O médico responsável pelo tratamento da DM não aprova a participação no estudo.· O doente teve alteração da dose oral de substâncias hipoglicemiantes e/ou dieta nas últimas 4 semanas anteriores à randomização. No caso das tiazolidionas (glitazonas) este período não pode ser inferior a 8 semanas.· Doente a fazer insulina cuja dose diária numa única ocasião nas últimas 4 semanas tenha sido 10% acima ou abaixo da dose média nas 4 semanas precedentes.Nota: Se um doente diabético apresenta um dos critérios acima referidos, o doente deverá ser excluído mesmo que o médico considere que o doente está estável e que pode participar no estudo. Após recepção dos resultados do laboratório da visita 1, o investigador descontinuará o doente se a HbA1c>8.5%.
    5.Evidência de doença clínica relevante, p.ex., insuficiência renal ou hepática, doença coronária significativa, insuficiência cardíaca, doença cerebrovascular, hepatite viral B ou C, síndrome da imunodeficiência adquirida (SIDA), segundo avaliação pelo investigador.
    6.Gravidez ou amamentação.
    7.Uso de indutores potentes do citocromo P450 3A4 (barbitúricos, carbamazepina, glucocorticoides, fenitoína, rifampicina, rifabutina, tioridazina e hipericão) nos 14 dias anteriores à randomização.
    8.Uso de inibidores potentes do citocromo P450 3A4 (antibióticos macrólidos, [claritromicina, reitromicina, troleandomicina], antifúngicos azol [fluconazol, itraconazol, cetoconazol excepto de uso tópico], inibidores da protease [indinavir, nelfinavir, ritonavir, saquinavir], fluvoxamina, nefazodona) nos 14 dias precendentes à randomização.
    9.Contraindicações descritas para o país – informação de prescrição específica para quetiapina XR e risperidona.
    10.Doentes com doença cardiovascular conhecida ou outras condições que predisponham para a hipotensão ou história familiar de prolongamento do intervalo QT.
    11.Doentes em risco iminente de cometer suicídio, baseado na avaliação do investigador.
    12.Doentes resistentes ao tratamento, definido como não tendo resposta à dose óptima de 2 antipsicóticos sucessivos.
    13.História conhecida de intolerância ou hipersensibilidade à quetiapina, risperidona ou outros componentes dos comprimidos.
    14. Ter sido administrada uma dose de medicação antipsicótica depot e a randomização ocorrer no período de intervalo entre as doses.
    15.Envolvimento no planeamento ou condução deste estudo (aplica-se tanto a empregados da AstraZeneca como a pessoal do centro do estudo).
    16.Inclusão ou randomização prévia neste estudo.
    17.Participação noutro ensaio clínico nas 4 semanas anteriores à randomização neste estudo (de acordo com os requisitos locais).
    18.Possíveis factores de risco de neutropénia incluindo pré-existência de baixa contagem de glóbulos brancos e história de indução de neutropénia pela substância (nota: após recepção dos resultados do laboratório da visita 1 o investigador descontinua o doente do estudo se a contagem absoluta de neutrófilos (CAN) ≤1,5x109 /L).
    E.5 End points
    E.5.1Primary end point(s)
    Eficácia
    Primeira variável: Taxa de resposta estimada a partir da alteração desde o baseline do valor total da escala SWN-K.
    Outras variáveis: Alterações na escala SWN-K desde o baseline.Taxa de remissão durante o estudo usando a escala SWN-K, definida como um total ≥ 80 pontos.Alterações na gravidade dos sintomas dos doentes usando a escala CGI-SCH.Alterações dos sintomas depressivos usando a CDSS.Taxa de recidivas em termos de sintomas e novas-hospitalizações.Adesão ao tratamento.Resposta aos questionários e alterações verificadas (EQ-5D e SWN-K).

    Farmacoeconomia
    Índice modificado de estatuto vocacional e índice modificado de código de localização;Dias perdidos de escola/trabalho;Número total de hospitalizações; Visitas de emergência e número de visitas em ambultório, tempo até re-hospitalização;Necessidade de tratamento adicional para a esquizofrenia devido a sintomas apesar de tratamento estável com antipsicóticos pelo menos por um mês.

    Segurança
    A segurança será avaliada em termos de efeitos adversos, descontinuações do estudo devido a efeitos adversos, resultados laboratoriais (Glicose, enzimas hepáticas, prolactina e contagem de neutrófilos), sinais vitais e registo de efeitos indesejáveis dos psicotrópicos usando a escala modificada Udvalg for Kliniske Undersogelser, Side Effect Rating scale (UKU)
    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
    To demonstrate the non-inferiority of quetiapine XR to risper
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 2008-01-11. 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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 732
    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 Decision2008-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-09
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