Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study.

ABSTRACT:

Purpose

The primary objective of this study was to assess long-term safety with sublingual asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia.

Patients and methods

Actively treated patients on asenapine 2.5 mg BID, asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to asenapine 2.5 mg BID treatment. Safety analyses were based on the all treated set (patients who received one or more doses of extension trial medication); change from baseline analyses used the acute study baseline. Treatment-emergent

SUBMITTER: Durgam S 

PROVIDER: S-EPMC5546824 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature