NCT00788944已完成4 期
An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
Wyeth is now a wholly owned subsidiary of Pfizer54 个研究点 分布在 1 个国家目标入组 971 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 971
- 试验地点
- 54
- 主要终点
- 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
研究概览
简要总结
This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).
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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women subjects aged 18 years or older.
- •Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less.
- •Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®.
排除标准
- •Determination by the investigator that a blood draw is contraindicated.
- •Participation in an investigational study within the past 30 days where the study medication is not known.
- •Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen.
- •Treatment with DVS SR within the last 30 days.
结局指标
主要结局
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
时间窗: 1 day
次要结局
- Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.(1 day)
研究者
研究点 (54)
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