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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/28/2008
 
Trade Name:  Zemuron
 
Generic or Proper Name (*):  rocuronium
 
Indications Studied:  Adjunct to general anesthesia
 
Therapeutic Category:  Anesthetic agent
 
Ages Studied:  0-17 years
 
Study #:  2
 
Study Type:  Safety/Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open Label/Dose Response
 
No Patients:  137
 
No Centers:  23
 
No Countries:  3
 
BPCA(B), PREA(P):  B, P
 
Asian:  9
 
Black:  7
 
Other:  0
 
White:  120
 
Native Hawaiian or Pacific Islander:  1
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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