Status:
COMPLETED
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
Eligibility Criteria
Inclusion
- 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
- Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
- Patients with Parkinson disease
- Patients who previously received blonanserin, etc.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT02287584
Start Date
December 1 2014
End Date
December 1 2018
Last Update
April 12 2022
Active Locations (8)
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1
3 Sites
Beijing, Etc., China
2
53 Sites
Tokyo Etc., Japan
3
14 Sites
Kuala Lumpur, Etc., Malaysia
4
9 Sites
Manila, Etc., Philippines