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Pediatric Studies Characteristics - Detail
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Pediatrics
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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