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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:
12-17 years
Study #:
1
Study Type:
Efficacy/Safety
Study Design:
Single-Blind/Placebo/Parallel Group/Dose Response
No Patients:
304
No Centers:
38
No Countries:
1
BPCA(B), PREA(P):
B, P
Asian:
1
Black:
65
Other:
5
White:
233
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
0
Non-Hispanic/Non Latino:
0
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