At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Autistic Disorder. Completed, enrolled 86 participants across 5 sites.
Detailed Summary
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2012
Primary CompletionOct 2016
TodayJul 2026
First PostedJun 12, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.1 years ago
Interventions
Aripiprazoledrug
Flexibly dose administered orally once daily