Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
9 de abril de 2019 atualizado por: Otsuka Pharmaceutical Europe Ltd
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.
The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.
Tipo de estudo
Observacional
Inscrição (Antecipado)
636
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alzey, Alemanha
- Retirado
- Rheinhessen-Fachklinik Alzey
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Berlin, Alemanha
- Retirado
- Vivantes Klinikum
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Dusseldorf, Alemanha
- Retirado
- LVR- Klinikum Düsseldorf
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Homburg, Alemanha
- Retirado
- Universitätsklinikum des Saarlandes
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Magdeburg, Alemanha
- Retirado
- Universitätsklinikum Magdeburg
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Taufkirchen, Alemanha
- Retirado
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Alcala de Henares, Espanha
- Retirado
- Hospital Príncipe de Asturias
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Barcelona, Espanha
- Recrutamento
- Hospital de Sant Pau
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Barcelona, Espanha
- Recrutamento
- Hospital del Mar
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Barcelona, Espanha
- Retirado
- Hospital Clínic de Barcelona
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Barcelona, Espanha
- Recrutamento
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, Espanha
- Recrutamento
- Hospital Universitario de Cruces
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Girona, Espanha
- Recrutamento
- Hospital santa Caterina -IAS
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Granada, Espanha
- Recrutamento
- Hospital Campus de la Salud
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Huelva, Espanha
- Retirado
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, Espanha
- Recrutamento
- Hospital de Jerez
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L'Hospitalet de Llobregat, Espanha
- Recrutamento
- Hospital Universitari de Bellvitge
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Madrid, Espanha
- Recrutamento
- Hospital Universitario 12 de Octubre
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Madrid, Espanha
- Recrutamento
- Hospital Fundación Jiménez Díaz
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Madrid, Espanha
- Retirado
- Hospital Clinico San Carlos
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Malaga, Espanha
- Retirado
- Hermanas Hospitalarias de Málaga
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Murcia, Espanha
- Retirado
- Hospital General Universitario Morales Meseguer
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Palma, Espanha
- Recrutamento
- Hospital Son Espases
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Sabadell, Espanha
- Retirado
- Hospital Parc Tauli
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Sant Boi de Llobregat, Espanha
- Recrutamento
- Hospital Sant Joan de Déu de Sant Boi
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Santander, Espanha
- Recrutamento
- Hospital Marqués de Valdecilla
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Toledo, Espanha
- Recrutamento
- Hospital Provincial de Toledo
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Valencia, Espanha
- Retirado
- Hospital Clinico Universitario de Valencia
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Valencia, Espanha
- Retirado
- Hospital Universitari i Politecnic La Fe
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Vic, Espanha
- Recrutamento
- Hospital de Vic
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Vigo, Espanha
- Recrutamento
- Hospital Alvaro Cunqueiro
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Zamora, Espanha
- Retirado
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, Espanha
- Recrutamento
- Hospital Punta de Europa
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Clamart, França
- Retirado
- H. Paul-Guiraud Clamart
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Jonzac, França
- Retirado
- CH Jonzac
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Laxou, França
- Retirado
- Centre Psychotherapique Nancy
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Limoges, França
- Retirado
- Centre Hospitalier Esquirol
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Montpellier, França
- Recrutamento
- CHS-La Colombière
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Nantes, França
- Retirado
- CHU Nantes Hospital Saint Jacques
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Nice, França
- Retirado
- CH Sainte Marie
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Nice, França
- Recrutamento
- CHU Pasteur
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Paris, França
- Recrutamento
- Hospital Maison Blanche XX Bichat
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Paris, França
- Retirado
- Hospital SAINTE ANNE
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Poitiers, França
- Recrutamento
- Centre Hospitalier Henri Laborit
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Rennes, França
- Recrutamento
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, França
- Recrutamento
- CHU-Saint Etienne
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Saint-Egreve, França
- Retirado
- Centre Hospitalier Alpes Isère
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Toulon, França
- Retirado
- CHITS - Hôpital Chalucet
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Vesoul, França
- Retirado
- CHS St. Remy
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Ancona, Itália
- Recrutamento
- Ospedali Riuniti di Ancona
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Bari, Itália
- Recrutamento
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore, Itália
- Recrutamento
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Itália
- Ainda não está recrutando
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Itália
- Recrutamento
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Itália
- Recrutamento
- Mental Health Department (MDSM) ASP di Messina
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Milan, Itália
- Recrutamento
- Ospedale Niguarda
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Modena, Itália
- Recrutamento
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Itália
- Recrutamento
- Centro Salute Mentale di Pesaro
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Roma, Itália
- Recrutamento
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Itália
- Ainda não está recrutando
- Fondazione PTV Policlinico Tor Vergara
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Rome, Itália
- Recrutamento
- Villa Maria Dia Hospital
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Salerno, Itália
- Recrutamento
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Itália
- Recrutamento
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Itália
- Recrutamento
- Centro di Salute Mentale
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San Benedetto del Tronto, Itália
- Recrutamento
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Itália
- Recrutamento
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Itália
- Recrutamento
- ASL di Teramo
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 35 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Eligible patients will include adult patients (≥18 years) with recent-onset (≤35 years old) schizophrenia who initiated maintenance treatment with AOM or an oral atypical AP during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge and which treatment was initiated before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country.
Prescription of the maintenance treatment had to be done in the usual manner in accordance with the terms of the marketing authorisation.
Descrição
Inclusion Criteria:
- Adult patients between ≥18 and ≤35 years of age
- Diagnosis of schizophrenia confirmed by the current investigator.
Initiation of maintenance treatment with AOM (at least one injection) or with daily oral atypical AP before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country, during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge, and prescribed in the usual manner in accordance with the terms of the marketing authorisation.*
Patients treated in the daycare hospital will be considered:
- Eligible to be included, if the patient was admitted in the hospital (full time inpatient stay) for an acute psychotic episode and then discharged to a day care hospital in order to achieve stabilization and initiate maintenance antipsychotic treatment. The initiation of the maintenance antipsychotic treatment (index date) must occur before discharge from day care hospital or during the immediate following three months after discharge.
NOT eligible, if the patient was treated exclusively in the day care hospital since the first day (i.e. not spending any night at all in the hospital) as these patients are very likely to be subacutely psychotic.
- The date of initiation of maintenance therapy will be considered the index date. For AOM, it is the date of the first injection. For the oral AP, this date is defined by the physician when patients are believed to be stable enough to be considered "in maintenance treatment".
Willingness to participate in the study; subjects must give their written consent to participate unless: they have discontinued treatment or have finished the 12 months follow up period before study inclusion (retrospective assessment only) and a) written consent not required by local regulations, or b) it would take a non-reasonable effort† or c) the source patient is deceased or untraceable.
- A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.
If allowable by local regulations/Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
Exclusion Criteria:
- The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- Chronically hospitalized patients (defined as more than 3 months).
- Participation in an interventional clinical trial since AOM or daily oral atypical AP were initiated as maintenance treatment or within the previous 6 months to this initiation.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Aripiprazole Once Monthly (AOM)
Schizophrenia patients who initiated maintenance treatment with AOM during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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Daily oral atypical AP
Schizophrenia patients who initiated maintenance treatment with any daily oral atypical AP during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Prazo: First 12 months after initiation of maintenance treatment
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Treatment discontinuation is defined as the interruption, replacement or addition of a new antipsychotic drug to the main antipsychotic initiated at index date (AOM or daily oral atypical AP).
|
First 12 months after initiation of maintenance treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Prazo: First 12 months after initiation of maintenance treatment
|
To compare the treatment discontinuation rate and the reasons for this discontinuation during the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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First 12 months after initiation of maintenance treatment
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|
Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Prazo: First 12 months after initiation of maintenance treatment
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To compare the relapse rate in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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First 12 months after initiation of maintenance treatment
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Change over time in CGI-S (score)
Prazo: From index date up to a maximun of 12 months
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To compare the evolution in disease severity according to Clinical Global Impression-Disease Severity (CGI-S) scale from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
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From index date up to a maximun of 12 months
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Change over time in QLS-5 (score)
Prazo: From index date up to a maximun of 12 months
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To compare the clinical and functional outcomes according to the 5-item Quality of Life Scale for schizophrenia (QLS-5) from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
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From index date up to a maximun of 12 months
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All-cause hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first all-cause hospitalisation and length of hospitalisation(admission/discharge dates)
Prazo: From index date up to a maximun of 12 months
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To compare all cause hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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From index date up to a maximun of 12 months
|
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Mental health-related hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first mental health-related hospitalisation and length of mental-health related hospitalisation (admission/discharge dates)
Prazo: From index date up to a maximun of 12 months
|
To compare mental health-related hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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From index date up to a maximun of 12 months
|
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Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Prazo: From index date up to a maximun of 12 months
|
To compare the health resource use related to schizophrenia in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
From index date up to a maximun of 12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
13 de julho de 2017
Conclusão Primária (Antecipado)
31 de janeiro de 2020
Conclusão do estudo (Antecipado)
31 de janeiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
21 de abril de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de abril de 2017
Primeira postagem (Real)
26 de abril de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de abril de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de abril de 2019
Última verificação
1 de abril de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 031-303-00136
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .