MedTrace Logo

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

NCT00044044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2014-04-17

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Conditions

Interventions

DRUG

Lurasidone 20 mg

Lurasidone 20mg/day tablets

DRUG

Lurasidone 40mg

Lurasidone 40mg/day tablets

DRUG

Lurasidone 80 mg

Lurasidone 80mg/day - 2 40mg tablets

DRUG

Haloperidol 10mg

Haloperidol 10mg/day tablets

DRUG

Placebo

Matching Placebo to Lurasdione and Haloperidol

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
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

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 NCT00044044 on ClinicalTrials.gov