NCT00152035已完成3 期
A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 505
- 主要终点
- The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
- •Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.
排除标准
- •Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
- •Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
- •History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- •Females who are pregnant of lactating.
结局指标
主要结局
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
时间窗: Throughout the study period of approximately 20 months
次要结局
- Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).(Baseline, Weekly for 4 weeks, and then Monthly for 5 months.)
- ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.(Baseline, Weekly for 4 weeks, and then Monthly for 5 months.)
- Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.(Baseline, Weekly for 4 weeks, and then Monthly for 5 months.)
研究者
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