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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  02/04/2010
 
Trade Name:  Benicar
 
Generic or Proper Name (*):  olmesartan
 
Indications Studied:  Hypertension
 
Therapeutic Category:  Antihypertensive
 
Ages Studied:  1-16 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  362
 
No Centers:  65
 
No Countries:  4
 
BPCA(B), PREA(P):  B, P
 
Asian:  40
 
Black:  152
 
Other:  31
 
White:  146
 
Native Hawaiian or Pacific Islander:  1
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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