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Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

NCT00615433 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2015-06-12

Study results available
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Summary

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Conditions

Interventions

DRUG

Lurasidone

120mg/day

DRUG

Olanzapine

15mg/day

DRUG

Placebo comparator

Placebor Comparator

DRUG

Lurasidone 40 mg tablets

Lurasidone 40 mg tablets

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States
  • Colombia
  • India
  • Lithuania
  • Philippines

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 NCT00615433 on ClinicalTrials.gov