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

NCT00790192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2016-03-17

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 short term among acutely psychotic patients with chronic schizophrenia.

Conditions

Interventions

DRUG

Lurasidone

Lurasidone 80 mg tablets

DRUG

Lurasidone

Lurasidone 4 40 mg tablets

DRUG

Quetiapine XR

Quetiapine XR 600mg

DRUG

Placebo

Matching Placebo to Lurasidone or Quetiapine

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
2008-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • India
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT00790192 on ClinicalTrials.gov