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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/15/2010
 
Trade Name:  Uroxatral
 
Generic or Proper Name (*):  alfuzosin
 
Indications Studied:  Elevated detrusor leak point pressure of neurologic origin
 
Therapeutic Category:  Urology
 
Ages Studied:  2-16 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  172
 
No Centers:  49
 
No Countries:  15
 
BPCA(B), PREA(P):  B
 
Asian:  26
 
Black:  5
 
Other:  4
 
White:  137
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  Canada (1), Estonia (1), France (3), Germany (2), India (4), Malaysia (1), Poland (6), Portugal (3), Russia (5), Serbia & Montenegro (3), Slovakia (2), Spain (5), Taiwan (2), Turkey (4), US (7)
 
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