JPRN-jRCT2080222637已完成3 期
Confirmatory Study of DSP-5423P in Patients with Schizophrenia <Phase 3>
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 580
研究概览
简要总结
The superiority of both DSP-5423P 40 mg and 80 mg to placebo was demonstrated in terms of change in PANSS total score at Week 6, analyzed as the primary endpoint. The long-term efficacy of DSP-5423P treatment was demonstrated. No safety concerns were noted in long-term DSP-5423P treatment. In the Japanese subpopulation, the efficacy of DSP-5423P showed similar trends to those seen in the overall pop, and there were no trends for marked differences in the safety profile compared with the overall pop.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •- Patients who fall under a contraindication listed in the LONASEN package insert
- •- Patients with Parkinson disease
- •- Patients who previously received blonanserin, etc.
研究者
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