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Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

NCT00711269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2022-04-12

Study results available
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Summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Conditions

Interventions

DRUG

SM-13496 (lurasidone HCl)

Lurasidone HCl: 40 mg/day

DRUG

SM-13496 (lurasidone HCl)

Lurasidone HCl: 80 mg/day

DRUG

Placebo

DRUG

Risperidone

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Drug Development Division · Sumitomo Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-27
Primary Completion
2010-04-27
Completion
2010-04-27

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

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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 NCT00711269 on ClinicalTrials.gov