Clinical Trials Directory

Trials / Completed

CompletedNCT00789698

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)

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

Summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Conditions

Interventions

TypeNameDescription
DRUGLurasidone HC1Lurasidone 40-160 mg/day flexibly dosed.
DRUGQuetiapine XRQuetiapine XR 200-800 mg/day flexibly dosed.

Timeline

Start date
2008-12-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2008-11-13
Last updated
2015-06-12
Results posted
2012-08-21

Locations

65 sites across 6 countries: United States, Colombia, India, Romania, Russia, Ukraine

Source: ClinicalTrials.gov record NCT00789698. Inclusion in this directory is not an endorsement.