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

NCT01614899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

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 40mg

once daily orally

DRUG

SM-13496 80mg

once daily orally

DRUG

Placebo

once daily orally

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Development 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
2012-07-02
Primary Completion
2014-11-17
Completion
2014-11-17

Countries

  • Japan
  • Malaysia
  • South Korea
  • Taiwan

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 NCT01614899 on ClinicalTrials.gov