EUCTR2012-003313-34-IT进行中（未招募）不适用
A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder - SPD489-345
适应症
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
- 530
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 in the study before all inclusion criteria (including test results) are confirmed.
- •All subjects must meet the following criteria:
- •Subject has completed 1 of the respective antecedent SPD489 BED trials.
- •Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent from the antecedent trial.
- •Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
- •Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings, clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
- •Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 530
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects that have a gap in participation of 30 days or more from completion of the antecedent study Follow-up Visit are excluded from the study if any of the following criteria are met:
- •Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
- •Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the Investigator’s assessment, and do not confound efficacy or safety assessments in the opinion of the examining Investigator may be included).
- •Subjects are excluded from the study if any of the following exclusion criteria are met:
- •Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- •Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
- •Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with Diagnostic Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
- •Subject has 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 medication.
- •Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- •Subjects with a history of moderate to severe hypertension or an average (of 3 readings) resting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry. Note: subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or more at the time of the Screening Visit (Visit -1) are allowed.
- •Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious disease process requiring antibiotics or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the Investigator’s opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
研究者
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