A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
| Tracking Information | |||||
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| First Received Date ICMJE | March 27, 2012 | ||||
| Last Updated Date | May 21, 2013 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01566162 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Twelve Week, Open Label Extension Study in Patients With Schizophrenia | ||||
| Official Title ICMJE | A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia | ||||
| Brief Summary | This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia. |
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| Detailed Description | This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: Lurasidone
Lurasidone 40-80 mg taken orally taken once daily |
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| Study Arm (s) | Experimental: Lurasidone
Lurasidone 40 - 80mg flexible dose
Intervention: Drug: Lurasidone |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, France, Italy, Russian Federation, Serbia, Slovakia, South Africa | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01566162 | ||||
| Other Study ID Numbers ICMJE | D1050307, 2011-004790-90 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sunovion | ||||
| Study Sponsor ICMJE | Sunovion | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sunovion | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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