EUCTR2008-000720-10-IT进行中（未招募）不适用
A phase III, open label, extension, multicenter, safety study of Lisdexanfetamine Dimesilate (LDX)in children and adolescent aged 6-17 with attention-deficit/hyperactivity disorder (ADHD) - ND
Shire UK0 个研究点目标入组 333 人开始时间: 2009年3月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 333
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
- •1. Before completing any study-related procedures, subject?s parent or legally authorised representative (LAR) must sign the informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in compliance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations. 2. Subject and parent/LAR are willing and able to comply with all the tests and requirements defined in this protocol, including supervision of morning dosage. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of test product for the whole duration of the study. 3. Subject is a male or female aged 6-17 years inclusive at the time of consent for the antecedent study (SPD489-325). 4. Subject satisfied all entry criteria for the previous study (SPD489-325), and completed a minimum of 4 weeks of double-blind treatment, reached Visit 4 and completed the 1-week post-treatment washout in the previous study (SPD489-325), without experiencing any clinically significant AE that would preclude exposure to LDX. 5. Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination outcomes, and clinical laboratory tests results. 6. Subject has blood pressure measures within the 95th percentile for age, gender, and height.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. Subject was withdrawn from SPD489-325 for non-compliance and/or experienced an SAE or an AE causing termination of the previous study. 2. Subject has a current, controlled (requiring a restricted treatment) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitation states, marked anxiety, or tension that, in the opinion of the examining clinician, contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1) of the previous study (SPD489-325) with the Screening interview of the Kiddie-SADS-Present and Lifetime ? Diagnostic Interview (K-SADS-PL) and additional modules if requested by the results of the initial interview. Participation in behavioural therapy, provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-325). 3. Subject has a conduct disorder. Oppositional defiant disorder is not an exclusion cause. 4. Subject has a concurrent chronic or acute disease or unstable medical condition that might confound the results of safety assessments, and cause difficulty in complying with the protocol. 5. Subject is currently considered at suicide risk, has previously made a suicide attempt or has a prior history of, or has currently, active suicidal intentions. 6. Subject is female and is pregnant or lactating. 7. Subject has glaucoma. 8. Subject has a clinically significant ECG at Visit 8 of the previous study (SPD489-325) or clinically significant laboratory abnormalities at Visit 7 of the previous study (SPD489-325). 9. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine. 10. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in compliance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition ? Text Revision (DSM-IV-TR) criteria. 11. Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, a current diagnosis and/or a known family history of Tourette?s Disorder. 12. Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that might increase vulnerability to the sympathomimetic effects of a stimulant drug. 13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia. 14. Subject is taking a forbidden drug . 15. Subject is taking other medications that have effects on central nervous system (CNS), affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of investigational drug administration). Stable use of bronchodilator inhalers is not an exclusion cause .
研究者
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