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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 #:
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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