NCT01338818已完成3 期
A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD
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
- 299
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
研究概览
简要总结
This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)
排除标准
- •Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
- •Patients who during the core study developed cardiovascular disorders.
- •Pregnant women.
- •Patients who developed seizures during the core study.
- •Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
- •Diagnosis or family history of Tourette's syndrome.
- •Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ritalin LA
Experimental
All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
干预措施: Ritalin LA (methylphenidate hydrochloride extended release) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
时间窗: Week 40 - Week 66
Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
次要结局
- Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score(week 40 - week 66)
- Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.(week 40 - week 66)
研究者
研究点 (1)
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