At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 92 enrolled
Drug / intervention
Placebo of Aripiprazole +1 moredrug
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 Short-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 Placebo of Aripiprazole and Aripiprazole for Autistic Disorder. Completed, enrolled 92 participants across 5 sites.
Detailed Summary
The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionJun 2015
TodayJul 2026
First PostedJun 12, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.1 years ago
Interventions
Placebo of Aripiprazoledrug
administered orally once daily
Aripiprazoledrug
Flexibly dose administered orally once daily