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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 #:  1
 
Study Type:  Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open Label
 
No Patients:  92
 
No Centers:  22
 
No Countries:  6
 
BPCA(B), PREA(P):  B
 
Asian:  1
 
Black:  5
 
Other:  5
 
White:  73
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  2
 
Hispanic/Latino:  9
 
Non-Hispanic/Non Latino:  77
 
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