At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 68 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 Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Schizophrenia. Completed, enrolled 68 participants across 8 sites.
Detailed Summary
The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedSep 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedSep 13, 2013
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.8 years ago
Interventions
Aripiprazoledrug