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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/26/2012
 
Trade Name:  Singulair Oral Granules, Tablets, and Chewable Tablets
 
Generic or Proper Name (*):  montelukast
 
Indications Studied:  Prevention of exercise-induced bronchoconstriction
 
Therapeutic Category:  Antiasthmatic
 
Ages Studied:  6-14 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Tolerability
 
Study Design:  Blind/Placebo
 
No Patients:  66
 
No Centers:  22
 
No Countries:  4
 
BPCA(B), PREA(P):  P
 
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