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NCT00576732 - Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety

Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety

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CSR Summary

Not Yet Available


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Risperidone
Product Name
RISPERDAL®
Therapeutic Area
Neurosciences
Enrollment
96
% Female
12.5%
% White
70.0%
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
RISAUT4002
Data Holder
Johnson & Johnson
Condition Studied
Autistic Disorder
Mean/Median Age (Years)
9.3

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
4

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.