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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  09/03/2008
 
Trade Name:  Valtrex
 
Generic or Proper Name (*):  valacyclovir
 
Indications Studied:  Chickenpox; active or at risk for herpes virus infection
 
Therapeutic Category:  Antiviral
 
Ages Studied:  1-<18 years
 
Study #:  3
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  27
 
No Centers:  7
 
No Countries:  4
 
BPCA(B), PREA(P):  B, P
 
Asian:  1
 
Black:  2
 
Other:  5
 
White:  19
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  27
 
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