NCT02250495终止1 期
VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Sympara Medical, Inc.6 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
- •Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
- •Minimum six- (6) month history of diagnosis and treatment of hypertension
排除标准
- •Previous renal denervation or carotid barostimulation implant
- •Secondary causes of hypertension or primary pulmonary hypertension
- •Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
- •Known or suspected baroreflex failure or significant orthostatic hypotension
- •One or more hospital admissions for a hypertensive crisis within the past year
- •History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
- •Diabetes mellitus (Type 1)
- •Chronic renal disease requiring dialysis
- •Kidney or liver transplant
结局指标
主要结局
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
时间窗: 30 days
次要结局
- Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy(30 days)
研究者
研究点 (6)
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