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

NCT00789698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-06-12

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 effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Conditions

  • Chronic Schizophrenia

Interventions

DRUG

Lurasidone HC1

Lurasidone 40-160 mg/day flexibly dosed.

DRUG

Quetiapine XR

Quetiapine XR 200-800 mg/day flexibly dosed.

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
2008-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Colombia
  • India
  • Romania
  • Russia
  • Ukraine

Study Locations

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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 NCT00789698 on ClinicalTrials.gov