NCT01642498已完成3 期
ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Change in mean office SBP
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination
排除标准
- •Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
研究组 & 干预措施
Group A
Experimental
ROX Coupler + continuing standard antihypertensive medications
干预措施: ROX COUPLER (Device)
Group B
No Intervention
Continuing standard antihypertensive medications
结局指标
主要结局
Change in mean office SBP
时间窗: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline
次要结局
- Change in mean office DBP(Baseline, 6 months)
研究者
研究点 (18)
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