Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Phase 3
Completed
NCT00337571
| Condition | Behavioral Symptoms, 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 | 218 participants |
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| Interventions | Aripiprazole |
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| Start date | Jun 1, 2006 |
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| Completion date | Jun 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 with placebo (fixed dose) 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 | -8.4 ± 1.39 units on a scale |
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| Aripiprazole 5 mg | -12.4 ± 1.36 units on a scale |
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| Aripiprazole 10 mg | -13.2 ± 1.25 units on a scale |
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| Aripiprazole 15 mg | -14.4 ± 1.31 units on a scale |
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Open in BENITIONS
View on ClinicalTrials.gov
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