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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/01/2009
 
Trade Name:  Patanase
 
Generic or Proper Name (*):  olopatadine
 
Indications Studied:  Seasonal allergic rhinitis
 
Therapeutic Category:  Antihistamine
 
Ages Studied:  2-11 years
 
Study #:  1
 
Study Type:  Efficacy/Safety 6 to <12 years
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  1188
 
No Centers:  173
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  217
 
Other:  75
 
White:  864
 
Native Hawaiian or Pacific Islander:  3
 
American Indian/Alaska Native:  1
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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