NCT00607477终止不适用
A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Magnitude of Change in Blood Pressure
研究概览
简要总结
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD
- •Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
- •Stable management of other toxicities from the cancer treatments
- •Expected to continue current cancer treatments for at least 4 weeks
- •18 years and older
- •Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.
排除标准
- •Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
- •Current uncontrolled toxicities due to the cancer treatments.
- •Patients having known contraindications to hydralazine or minoxidil therapy.
- •Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
- •Use of either minoxidil or hydralazine in the six (6) months prior to screening.
研究组 & 干预措施
1
Active Comparator
Minoxidil
干预措施: Minoxidil (Drug)
2
Active Comparator
Hydralazine
干预措施: Hydralazine (Drug)
结局指标
主要结局
Magnitude of Change in Blood Pressure
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
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