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Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

NCT00641745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2015-06-22

Study results available
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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 safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Conditions

Interventions

DRUG

Lurasidone HCl

40 - 120mg per day

DRUG

Risperidone

Risperidone

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Croatia
  • Israel
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00641745 on ClinicalTrials.gov