Clinical Trials Directory

Trials / Completed

CompletedNCT00790192

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
488 (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 short term among acutely psychotic patients with chronic schizophrenia.

Conditions

Interventions

TypeNameDescription
DRUGLurasidoneLurasidone 80 mg tablets
DRUGLurasidoneLurasidone 4 40 mg tablets
DRUGQuetiapine XRQuetiapine XR 600mg
DRUGPlaceboMatching Placebo to Lurasidone or Quetiapine

Timeline

Start date
2008-10-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2008-11-13
Last updated
2016-03-17
Results posted
2011-10-06

Locations

65 sites across 5 countries: United States, India, Romania, Russia, Ukraine

Source: ClinicalTrials.gov record NCT00790192. Inclusion in this directory is not an endorsement.