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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
Asian:  1