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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/05/2008
 
Trade Name:  Arimidex
 
Generic or Proper Name (*):  anastrozole
 
Indications Studied:  Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty
 
Therapeutic Category:  Estrogen lowering agent
 
Ages Studied:  10 years and older
 
Study #:  3
 
Study Type:  Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  38
 
No Centers:  2
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  9
 
Other:  4
 
White:  25
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  5
 
Non-Hispanic/Non Latino:  0
 
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