Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
NCT ID: NCT03179787
Last Updated: 2021-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
528 participants
OBSERVATIONAL
2017-04-01
2020-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Aripiprazole oral product
oral administration of aripiprazole
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
17 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Pharmacovigilance
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Otsuka Pharmaceutical Co., Ltd.
Tokyo, , Japan
Countries
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References
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Sugimoto Y, Yamamura K, Takayama T, Fukuta Y, Aoki K, Mikami K, Tomoda A. Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. BMC Psychiatry. 2021 Apr 22;21(1):204. doi: 10.1186/s12888-021-03201-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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031-101-00116
Identifier Type: -
Identifier Source: org_study_id
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