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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  09/28/2010
 
Trade Name:  Kapvay Extended Release Tablets
 
Generic or Proper Name (*):  clonidine
 
Indications Studied:  Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
Ages Studied:  6-17 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  236
 
No Centers:  15
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  62
 
Other:  12
 
White:  135
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  19
 
Non-Hispanic/Non Latino:  0
 
Countries:  US
 
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