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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 #:  1
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label
 
No Patients:  27
 
No Centers:  4
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  14
 
Other:  0
 
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