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Pediatric Studies Characteristics - Detail
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Pediatrics
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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