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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  04/30/2008
 
Trade Name:  Cardiolite
 
Generic or Proper Name (*):  technetium tc99m sestamibi
 
Indications Studied:  Medical imaging in Kawasaki disease
 
Therapeutic Category:  Diagnostic aid
 
Ages Studied:  4-17 years
 
Study #:  3
 
Study Type:  Efficacy/Safety
 
Study Design:  Other
 
No Patients:  86
 
No Centers:  19
 
No Countries:  5
 
BPCA(B), PREA(P):  B, P
 
Asian:  53
 
Black:  3
 
Other:  8
 
White:  21
 
Native Hawaiian or Pacific Islander:  1
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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