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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:  < 48 hours old
 
Study #:  3
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo
 
No Patients:  793
 
No Centers:  16
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  7
 
Black:  192
 
Other:  9
 
White:  483
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  13
 
Hispanic/Latino:  89
 
Non-Hispanic/Non Latino:  0
 
Countries:  US
 
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