Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 April 2022 |
Main ID: |
NCT02287584 |
Date of registration:
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06/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Confirmatory Study of DSP-5423P in Patients With Schizophrenia
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Scientific title:
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Confirmatory Study of DSP-5423P in Patients With Schizophrenia |
Date of first enrolment:
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December 2014 |
Target sample size:
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580 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02287584 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Japan
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Korea, Republic of
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Malaysia
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Philippines
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Russian Federation
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Taiwan
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Ukraine
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Contacts
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Name:
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Director, Drug Development Division |
Address:
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Telephone:
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Email:
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Affiliation:
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Sumitomo Pharma Co., Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
- Patients who are aged 18 years or older at informed consent
- Patient understands the objectives and procedures of the study and who provide written
voluntarily consent to participate in the study, etc.
Exclusion Criteria:
- Patients who fall under a contraindication listed in the blonanserin (LONASEN) package
insert
- Patients with Parkinson disease
- Patients who previously received blonanserin, etc.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: DSP-5423P 80mg
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Drug: DSP-5423P 40mg
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Drug: DSP-5423P Active-to-Flex
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Drug: DSP-5423P Placebo
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Drug: DSP-5423P Placebo-to-Flex
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Primary Outcome(s)
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Change in PANSS Total Score From Baseline at Week 6
[Time Frame: Week 6]
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Secondary Outcome(s)
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Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
[Time Frame: Week 6 (LOCF)]
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Treatment Continuation Rate at 28 Weeks and 52 Weeks
[Time Frame: Open-Week 28 and Open-Week 52 in the open-label treatment phase]
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Secondary ID(s)
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D4904020
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JapicCTI-142688
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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