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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/08/2008
 
Trade Name:  Desmopressin acetate Tablets, 0.1 mg and 0.2 mg
 
Generic or Proper Name (*):  desmopressin acetate
 
Indications Studied:  Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE)
 
Therapeutic Category:  Urology
 
Ages Studied:  3-18 years
 
Study #:  6
 
Study Type:  Efficacy
 
Study Design:  Open Label
 
No Patients:  38
 
No Centers:  11
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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