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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 #:  1
Study Type:  Efficacy/Safety
Study Design:  Single-Blind/Placebo
No Patients:  145
No Centers:  6
No Countries:  1