A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 3
- 主要终点
- Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
研究概览
简要总结
This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).
详细描述
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age > 65 years.
- •A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
- •Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.
排除标准
- •Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
- •Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
- •Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
- •Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.
结局指标
主要结局
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
时间窗: Weekly
The nature, incidence, duration, and severity of adverse events.
时间窗: Weekly
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed
时间窗: As needed
The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory
时间窗: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound
时间窗: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT
次要结局
- Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.(Twice at Wk 13 and Wk 26/EOT)
- Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A).(Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU))
- Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD.(Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT)
- Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .(1 time)