EUCTR2009-011745-94-IT进行中（未招募）不适用
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel group Study to Assess the Time to Response to Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 262
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject has had an historical or current inadequate response to MPH treatment. IInadequate response includes but is not limited to the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. • Subject is a male or female aged 6-17 years inclusive at the time of consent • Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. â?? Text Revision (DSM IV TRï??) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation • Subject must have a baseline ADHD-RS-IV total score ï?³28 at the Baseline Visit (Visit 0).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has taken >1 MPH treatment (for example, ï?³2 different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, ï?£4 weeks) with an adequate response. • In the investigators judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms. • Subject has previously been exposed to STRATTERA or to amphetamine therapy. • Subject has previously demonstrated intolerable side effects to 1 or more MPH treatment. • Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established using the Kiddie Schedule for Affective Disorders-Present and Lifetime (K SADS-PL) diagnostic interview at screening, and additional modules if warranted by the results of the initial interview. Subjects may continue participating in behavioural therapy during this study as long as they have been receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0). • Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary • Other safety exclusions based on the known safety profile of the investigational medicinal products.
研究者
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