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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  01/31/2008
 
Trade Name:  Inspra
 
Generic or Proper Name (*):  eplerenone
 
Indications Studied:  Hypertension
 
Therapeutic Category:  Antihypertensive
 
Ages Studied:  6-16 years
 
Study #:  2
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  149
 
No Centers:  20
 
No Countries:  3
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  4
 
Other:  48
 
White:  97
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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