NCT00174265已完成3 期
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
研究概览
简要总结
This is an extension study of A7501013 (P05771/NCT00145496) to further test
the efficacy and safety of Asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continue to meet all demographic and procedural
- •inclusion criteria of the A7501013 trial to enter into
- •this extension trial.
- •Have demonstrated an acceptable degree of compliance
- •and completed the A7501013 trial, and would benefit
- •from continued treatment according to the investigator.
排除标准
- •Have an uncontrolled, unstable clinically significant
- •medical condition.
- •Have been judged to be medically noncompliant in the
- •management of their disease.
研究组 & 干预措施
asenapine
Experimental
干预措施: asenapine (Drug)
olanzapine
Active Comparator
干预措施: olanzapine (Drug)
结局指标
主要结局
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
时间窗: Baseline of A7501013 to Day 365
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.
次要结局
- Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score(Baseline of A7501013 to Day 365)
研究者
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