Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
研究概览
简要总结
The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ambulatory outpatients 18-79 years old at screening
- •Minimum 2-year history of Stage I/II hypertension
- •Qualifying blood pressure criteria for study entry and for randomization
- •Willing to adhere to the dietary compliance and undergo protocol procedures
- •Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days
排除标准
- •Have any form of secondary hypertension
- •Have clinically significant respiratory or cardiovascular disease
- •Presence/history of coronary artery disease or peripheral vascular disease
- •Have diabetes mellitus, Type I or II
- •Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
研究组 & 干预措施
1
Nebivolol
干预措施: Nebivolol (Drug)
2
Metoprolol ER (TM)
干预措施: Metoprolol ER (TM) (Drug)
结局指标
主要结局
Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
时间窗: Before treatment and after 10 weeks
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).
次要结局
未报告次要终点