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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
03/24/2008
Trade Name:
Depakote ER Depakote Sprinkles
Generic or Proper Name (*):
divalproex disodium
Indications Studied:
Pediatric Bipolar Disorder; Prophylaxis of Migraine
Therapeutic Category:
Anticonvulsant; Mood Stablizer
Ages Studied:
3-10 years
Study #:
3
Study Type:
Safety
Study Design:
Open Label
No Patients:
169
No Centers:
29
No Countries:
2
BPCA(B), PREA(P):
B, P
Asian:
0
Black:
20
Other:
3
White:
146
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
13
Non-Hispanic/Non Latino:
0
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