ISRCTN56637853已完成不适用
A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.
TT Bio-Pharma (Japan)0 个研究点目标入组 72 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •2. Willing and able to give written informed consent
- •3. Between 20 - 75 years of age
- •4. Scheduled for the current clinical routine protocol for adjuvant chemotherapy for carcinoma of the breast consisting of doxorubicin/cyclophosphamide cycles
排除标准
- •1. Patients with indication of distant metastases of breast carcinoma
- •2. Inability to obtain a good quality echocardiogram before study drug administration
- •3. Patients who are unable to remain in supine condition for more than one hour
- •4. Patients with (a history of) malignant disease other than carcinoma of the breast
- •5. Patients with hepatic disorders evidenced by elevated transamines above three times the upper limit of normal
- •6. Patients with a renal disorder requiring renal replacement therapy
- •7. Patients with a life expectancy of less than one year for whatever clinical condition
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