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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  11/29/2007
 
Trade Name:  Diovan
 
Generic or Proper Name (*):  valsartan
 
Indications Studied:  Hypertension
 
Therapeutic Category:  Antihypertensive
 
Ages Studied:  1-16 years
 
Study #:  2
 
Study Type:  Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group/Dose Response
 
No Patients:  261
 
No Centers:  55
 
No Countries:  9
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  128
 
Other:  7
 
White:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  126
 
Non-Hispanic/Non Latino:  0
 
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