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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  11/09/2011
 
Trade Name:  Chantix
 
Generic or Proper Name (*):  varenicline
 
Indications Studied:  Smoking cessation
 
Therapeutic Category:  Smoking cessation
 
Ages Studied:  12-16 year
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Single-Blind/Parallel Group/Traditional Pharmacokinetic
 
No Patients:  73
 
No Centers:  17
 
No Countries:  2
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  0
 
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