At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 330 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 15 mgfrom 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 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 18, 2006·Updated Dec 2, 2013
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Autistic Disorder and Behavioral Symptoms. Completed, enrolled 330 participants across 55 sites.
Detailed Summary
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder, Behavioral Symptoms
CountriesUnited States
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartSep 2006
Primary CompletionJun 2009
TodayJul 2026
First PostedAug 18, 2006
Enrollment StartSep 1, 2006
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.9 years ago
Interventions
Aripiprazoledrug
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks