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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/14/2008
 
Trade Name:  Zyprexa
 
Generic or Proper Name (*):  olanzapine
 
Indications Studied:  schizophrenia; bipolar disorder
 
Therapeutic Category:  Antipsychotic
 
Ages Studied:  13-17 years
 
Study #:  2
 
Study Type:  Pharmacokinetic
 
Study Design:  Open label/Population Pharmacokinetic
 
No Patients:  107
 
No Centers:  22
 
No Countries:  2
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  9
 
Other:  0
 
White:  91
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  7
 
Non-Hispanic/Non Latino:  0
 
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