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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/06/2011
 
Trade Name:  Plavix
 
Generic or Proper Name (*):  clopidogrel bisulfate
 
Indications Studied:  Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease
 
Therapeutic Category:  Platelet inhibitor
 
Ages Studied:  neonates - 24 months
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo
 
No Patients:  906
 
No Centers:  134
 
No Countries:  31
 
BPCA(B), PREA(P):  B
 
Asian:  133
 
Black:  54
 
Other:  12
 
White:  639
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  1
 
American Indian/Alaska Native:  63
 
Hispanic/Latino:  220
 
Non-Hispanic/Non Latino:  686
 
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