Trials / Completed
CompletedNCT01617460
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole | Flexibly dose administered orally once daily |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2012-06-12
- Last updated
- 2024-08-06
- Results posted
- 2017-10-20
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01617460. Inclusion in this directory is not an endorsement.