drugset
drugset / Trial / NCT01614899

A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

NCT01614899 ↗

Phase 3 Completed 457 enrolled Sumitomo Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Timeline

Start
2012-07-02
Primary completion
2014-11-17
Completion
2014-11-17

Outcome

Missed primary endpoint

registry analysis (superiority test); SM-13496 (Lurasidone HCl) 40mg vs Placebo; p = 0.050; LS Mean difference -4.8 (95% CI -9.52 to 0.00); NCT01614899 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 40 mg Oral
Subject Lurasidone Small molecule 80 mg Oral

Indications

schizophrenia