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NCT01624675 - A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder


Primary Citation

Not Available


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Risperidone
Product Name
RISPERDAL®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
39
% Female
23.1%
% White
N/A
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
RIS-AUT-JPN-01
Data Partner
Johnson & Johnson
Condition Studied
Autistic Disorder
Mean/Median Age (Years)
8.0

Supporting Documentation

Clinical Study Report
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3
Additional Information: 

Please note: individual participant-level data are not available for this trial. Only the protocol with amendments, statistical analysis report, and clinical study report are available.

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.