To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
995
Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Treatment Emergent Adverse Events
Number of patients with treatment emergent adverse events
Time frame: Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
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