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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/22/2009
 
Trade Name:  Flomax
 
Generic or Proper Name (*):  tamsulosin
 
Indications Studied:  Treatment of elevated detrusor leak point pressure associated with neurological disorder
 
Therapeutic Category:  Urology
 
Ages Studied:  2-16 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Single-Blind/Placebo/Parallel Group/Population Pharmacokinetic
 
No Patients:  161
 
No Centers:  3
 
No Countries:  3
 
BPCA(B), PREA(P):  B
 
Asian:  89
 
Black:  10
 
Other:  0
 
White:  44
 
Native Hawaiian or Pacific Islander:  18
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  25
 
Non-Hispanic/Non Latino:  136
 
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