Status:
COMPLETED
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT00615433
Start Date
January 1 2008
End Date
January 1 2010
Last Update
June 12 2015
Active Locations (52)
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1
K&S Professional Research Services LLC
Little Rock, Arkansas, United States, 72201
2
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
3
Clinical Pharmacological Studies, Inc.
Cerritos, California, United States, 90703
4
Excell Research
Oceanside, California, United States, 92056