EUCTR2008-000720-10-FR进行中（未招募）1 期
A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
Shire Pharmaceutical Development Limited0 个研究点目标入组 276 人开始时间: 2008年5月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
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
- •The subject cannot be enrolled before all inclusion criteria (including test results) are confirmed.
- •Subjects meeting all of the criteria listed below will be included in the study:
- •1. Subject’s parent or legally authorised representative (LAR) must provide signature of 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 accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study-related procedures.
- •2. Subject and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of test product for the 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 antecedent 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 antecedent study (SPD489-325), without experiencing any clinically significant adverse events (AEs) 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 findings, 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
- •Subjects are excluded from the study if any of the following criteria are met at Visit 1 or if they are reassessed:
- •1. Subject was terminated from SPD489-325 for non-compliance and/or experienced a serious adverse event (SAE) or AE resulting in termination from the antecedent study.
- •2. 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 (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 agitated states, marked anxiety, or tension that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1) of the antecedent study (SPD489-325) with the Screening interview of the Kiddie-SADS-Present and Lifetime – Diagnostic Interview (K-SADS-PL) and additional modules if warranted 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 exclusionary.
- •4. Subject has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- •5. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- •6. Subject is female and is pregnant or lactating.
- •7. Subject has glaucoma.
- •8. Subject has any clinically significant ECG at Visit 8 of the antecedent study (SPD489 325) or clinically significant laboratory abnormalities at Visit 7 of the antecedent 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 accordance with 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 may place them at increased 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 any medication that is excluded.
- •15. Subject is taking other medications that have central nervous system (CNS) effects, affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test product administration). Stable use of bronchodilator inhibitors is not exclusionary.
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