Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
Phase 3
Completed
NCT00332241
| Condition | Autistic Disorder |
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| Phase | Phase 3 |
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| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status | Completed |
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| Enrollment | 98 participants |
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| Interventions | Aripiprazole |
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| Start date | Jun 1, 2006 |
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| Completion date | Apr 1, 2008 |
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| Results posted | Jul 23, 2009 |
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Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
Week 8 · units on a scale
| Placebo | -5.0 ± 1.43 units on a scale |
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| Aripiprazole | -12.9 ± 1.44 units on a scale |
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Open in BENITIONS
View on ClinicalTrials.gov
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