NCT01012375已完成2 期
A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety ,Tolerability and Pharmacokinetics of Three Oral AZD1446 Dose Regimens and Placebo During 2 Weeks of Treatment in Adult Non-Users and Users of Nicotine Containing Products
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
- 135
- 试验地点
- 1
- 主要终点
- AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
研究概览
简要总结
The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •A confirmed diagnosis of ADHD
- •Patient understands and is willing to comply with all study requirements
- •Adults between the ages of 18-65 inclusive
排除标准
- •Current psychiatric disorder other than ADHD
- •Previous randomization into this study
- •Women with a positive pregnancy test
研究组 & 干预措施
1
Experimental
AZD1446 tid
干预措施: AZD1446 (Drug)
2
Experimental
AZD1446 tid
干预措施: AZD1446 (Drug)
3
Experimental
AZD1446 qd
干预措施: AZD1446 (Drug)
4
Placebo Comparator
Matching placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
时间窗: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
次要结局
- To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring(Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15)
- To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.(From enrollment visit to follow up)
- To evaluate the pharmacokinetics (PK) of AZD1446.(Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected)
研究者
研究点 (1)
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