NCT00615433

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone	120mg/day
DRUG	Olanzapine	15mg/day
DRUG	Placebo comparator	Placebor Comparator
DRUG	Lurasidone 40 mg tablets	Lurasidone 40 mg tablets

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-02-14
• Last updated: 2015-06-12
• Results posted: 2011-02-14

Locations

52 sites across 5 countries: United States, Colombia, India, Lithuania, Philippines