A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 468
- 试验地点
- 94
- 主要终点
- The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
研究概览
简要总结
This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
- •Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.
排除标准
- •Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
- •Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
- •Serious suicidal risk per the clinical investigators's judgement.
结局指标
主要结局
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
时间窗: Screening, Wk 25 & Wk 52/EOT
Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes
时间窗: Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
时间窗: As needed
The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically
时间窗: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
时间窗: Weekly
次要结局
- The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period.(Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT)
- The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period.(Baseline, Wk 51 & Wk 52/EOT)
- The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period.(Baseline, Wk 12, Wk 25, Wk 38 & Wk 51)