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Aripiprazole in Children and Adolescents With Autistic Disorder
NCT00365859Phase 3Completed
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization
- Start
- Sep 2006
- Primary completion
- Jun 2009
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label trial of aripiprazole in Autism Spectrum Disorder (ASD) (3 arms), sponsored by Otsuka Pharmaceutical Development & Commercialization. Primary endpoints: Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs at Week 52, Simpson-Angus Scale at Week 52 and 11 more. Started Sep 2006; status: completed.
02
Drugs
aripiprazole
03
Conditions
Autism Spectrum Disorder (ASD)
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