NCT00784862已完成3 期
A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 9,358
- 主要终点
- Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole
研究概览
简要总结
To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible for entry into the main ATAC trial 1033IL/0029
- •Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)
- •Patients should be taking their medication in the mornings for at least 3 months
- •Patients must be 100% compliant over the preceding fourteen days
排除标准
- •Excluded from entry into the main ATAC trial (1033IL/0029)
- •Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds
研究组 & 干预措施
1
Active Comparator
Arimidex 1mg + Nolvadex placebo
干预措施: Anastrozole (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Anastrozole (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Tamoxifen (Drug)
3
Active Comparator
Arimidex 1mg + Nolvadex 20mg
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole
时间窗: 24±4 hours after previous dose
次要结局
未报告次要终点
研究者
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