CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 215 enrolled
Drug / intervention
Aripiprazole +1 moredrug
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.

Search/NCT01227668
NCT01227668Phase 4Completed
CompareCT.gov

Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

Bristol-Myers Squibb·interventional·Posted Oct 25, 2010·Updated May 2, 2014

In Brief

A Phase 4 clinical trial evaluating Aripiprazole and Placebo for Irritability Associated With Autistic Disorder. Completed, enrolled 215 participants across 38 sites.

Detailed Summary

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritability Associated With Autistic Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago

Interventions

Aripiprazoledrug

Tablets, Oral, 2-15 mg, once daily, 13-42 weeks

Placebodrug

Tablets, Oral, 0 mg, once daily, 16 weeks