A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
NCT ID: NCT01614899
Last Updated: 2022-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
457 participants
INTERVENTIONAL
2012-07-02
2014-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SM-13496 40mg
SM-13496 40mg
once daily orally
SM-13496 80mg
SM-13496 80mg
once daily orally
Placebo
Placebo
once daily orally
Interventions
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SM-13496 40mg
once daily orally
SM-13496 80mg
once daily orally
Placebo
once daily orally
Eligibility Criteria
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Inclusion Criteria
* Patient is aged 18 through 74 years at informed consent.
* Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
Exclusion Criteria
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.
18 Years
74 Years
ALL
No
Sponsors
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Sumitomo Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Drug development Division
Role: STUDY_DIRECTOR
Sumitomo Pharma Co., Ltd.
Locations
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69 Sites
Tokyo, Etc, , Japan
10 Sites
Kuala Lumpur, Etc, , Malaysia
22 Sites
Seoul, Etc, , South Korea
14 Sites
Taipei, Etc, , Taiwan
Countries
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Other Identifiers
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JapicCTI-121859
Identifier Type: REGISTRY
Identifier Source: secondary_id
D1001056
Identifier Type: -
Identifier Source: org_study_id
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