Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Phase 3
Completed
NCT00365859
| Condition | Autistic Disorder, Behavioral Symptoms |
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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 | 330 participants |
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| Interventions | Aripiprazole |
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| Start date | Sep 1, 2006 |
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| Completion date | Jun 1, 2009 |
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| Results posted | Jan 25, 2010 |
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Summary
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs
From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs · Participants
| De Novo | 0 Participants |
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| Rollover Placebo | 0 Participants |
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| Rollover Aripiprazole | 0 Participants |
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| Total | 0 Participants |
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| De Novo | 3 Participants |
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| Rollover Placebo | 1 Participants |
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Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52
Baseline, Week 8, Week 26, Week 52 · units on a scale
| De Novo | 10.7 ± 1.40 units on a scale |
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| Rollover Placebo | 10.6 ± 1.17 units on a scale |
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| Rollover Aripiprazole | 11.0 ± 2.11 units on a scale |
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| Total | 10.8 ± 1.77 units on a scale |
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| De Novo | -0.3 ± 1.13 units on a scale |
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| Rollover Placebo | 0.1 ± 1.51 units on a scale |
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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52
Baseline, Week 8, Week 26, Week 52 · units on a scale
| De Novo | 0.5 ± 1.90 units on a scale |
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| Rollover Placebo | 0.5 ± 1.02 units on a scale |
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| Rollover Aripiprazole | 0.3 ± 1.23 units on a scale |
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| Total | 0.4 ± 1.40 units on a scale |
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| De Novo | -0.3 ± 1.45 units on a scale |
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| Rollover Placebo | -0.1 ± 0.87 units on a scale |
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Open in BENITIONS
View on ClinicalTrials.gov
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