Status:
COMPLETED
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
Eligibility Criteria
Inclusion
- Main
- Patient meets DSM-IV criteria for schizophrenia.
- Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
- Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.
- Main
Exclusion
- Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- Patient has Parkinson's disease.
- Patient has a history or complication of malignancy.
Key Trial Info
Start Date :
June 27 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2010
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00711269
Start Date
June 27 2008
End Date
April 27 2010
Last Update
April 12 2022
Active Locations (3)
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1
Japan: 67 sites
Tokyo, Etc., Japan
2
Korea: 14 sites
Seoul, Etc., South Korea
3
Taiwan: 11 sites
Taipei, Etc., Taiwan