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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/02/2009
 
Trade Name:  Seroquel
 
Generic or Proper Name (*):  quetiapine
 
Indications Studied:  Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age
 
Therapeutic Category:  Antipsychotic
 
Ages Studied:  10 - 17 years
 
Study #:  4
 
Study Type:  Safety/Tolerability
 
Study Design:  Open Label
 
No Patients:  380
 
No Centers:  59
 
No Countries:  11
 
BPCA(B), PREA(P):  B, P
 
Asian:  38
 
Black:  45
 
Other:  43
 
White:  218
 
Native Hawaiian or Pacific Islander:  7
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  29
 
Non-Hispanic/Non Latino:  0
 
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