NCT00921804已完成2 期
A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- PANSS Total Score
研究概览
简要总结
The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient will need to read, understand and sign an informed consent prior to any study specific procedures
- •Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry
排除标准
- •Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
- •Patients will be excluded if urine drug screen test show positive results
- •Smoking of more than 2 packs of cigarettes a day
研究组 & 干预措施
1
Experimental
AZD8529 40 mg
干预措施: AZD 8529 (Drug)
1
Experimental
AZD8529 40 mg
干预措施: Placebo to match risperidone (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo to match AZD8529 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo to match risperidone (Drug)
3
Other
Risperidone 4 mg (2mg on Day 1)
干预措施: Risperidone (Drug)
3
Other
Risperidone 4 mg (2mg on Day 1)
干预措施: Placebo to match AZD8529 (Drug)
结局指标
主要结局
PANSS Total Score
时间窗: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
次要结局
- PANSS Positive, Negative, and General Psychopathology Subscale Scores(Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28)
- CGI-S(Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28)
- Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events(Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28)
研究者
研究点 (1)
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