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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  11/19/2009
 
Trade Name:  Abilify
 
Generic or Proper Name (*):  aripiprazole
 
Indications Studied:  Irritability associated with autistic disorder
 
Therapeutic Category:  Antipsychotic
 
Ages Studied:  6-17 years
 
Study #:  2
 
Study Type:  Efficacy/Safety/Tolerability
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  368
 
No Centers:  37
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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