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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/21/2009
 
Trade Name:  Xyzal
 
Generic or Proper Name (*):  levocetirizine dihydrochloride
 
Indications Studied:  Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older
 
Therapeutic Category:  Antihistamine
 
Ages Studied:  6 months and older
 
Study #:  2
 
Study Type:  Safety
 
Study Design:  Single-Blind
 
No Patients:  69
 
No Centers:  25
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  1
 
Black:  54
 
Other:  30
 
White:  157
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  28
 
Non-Hispanic/Non Latino:  214
 
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