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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/21/2010
 
Trade Name:  INOmax
 
Generic or Proper Name (*):  nitric oxide
 
Indications Studied:  Prevention of bronchopulmonary dysplasia
 
Therapeutic Category:  Pulmonary vasodilator
 
Ages Studied:  2-26 hours
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo
 
No Patients:  792
 
No Centers:  35
 
BPCA(B), PREA(P):  B
 
Asian:  6
 
Black:  87
 
Other:  48
 
White:  651
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  Throughout Europe including Spain and Sweden
 
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