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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/05/2008
 
Trade Name:  Zetia and Vytorin
 
Generic or Proper Name (*):  ezetimibe and ezetimibe/ simvastatin
 
Indications Studied:  Heterozygous familial hypercholesterolemia as an adjunct to diet
 
Therapeutic Category:  Antilipemic
 
Ages Studied:  10-17 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Active Control/Parallel Group
 
No Patients:  246
 
No Centers:  47
 
No Countries:  2
 
BPCA(B), PREA(P):  B, P
 
Asian:  9
 
Black:  4
 
Other:  32
 
White:  203
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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