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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/19/2008
 
Trade Name:  Casodex
 
Generic or Proper Name (*):  bicalutamide
 
Indications Studied:  Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis)
 
Therapeutic Category:  Androgen blocker
 
Ages Studied:  2 years and older
 
Study #:  1
 
Study Type:  Efficacy
 
Study Design:  Open Label/Active Control/Parallel Group
 
No Patients:  14
 
No Centers:  10
 
No Countries:  3
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  1
 
Other:  1
 
White:  12
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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