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COMPLETEDPhase 3NCT00790192

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

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 wi...

Lead sponsor: Sumitomo Pharma America, Inc.•29 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sumitomo Pharma America, Inc.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Provide written informed consent and aged between 18 and 75 years of age.
•Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
•Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
•Able and agrees to remain off prior antipsychotic medication for the duration of study.
•Good physical health on the basis of medical history, physical examination, and laboratory screening.
•Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria

•Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
•Any chronic organic disease of the CNS (other than schizophrenia).
•Used investigational compound within 30 days.
•Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 17, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment488

Start dateOct 2008

Last updatedMar 17, 2016

Condition

Locations shown

K&S Professional Research Services, LLC

Little Rock, Arkansas

Woodland International Research Group

Little Rock, Arkansas

Clinical Pharmacological Studies, Inc.

Cerritos, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2016Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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