NCT00847899已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
Arete Therapeutics2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Systolic and Diastolic blood pressure
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate hypertension
- •naive to antihypertensive medication or on two or less antihypertensive medications
- •impaired glucose tolerance
- •mild obesity
排除标准
- •Diagnosis of Type 1 or Type 2 diabetes
- •History of severe heart failure
- •AST, ALT levels more than twice the normal range
研究组 & 干预措施
1
Active Comparator
AR9281
干预措施: AR9281 (Drug)
2
Active Comparator
AR9281
干预措施: AR9281 (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic and Diastolic blood pressure
时间窗: 28 day treatment period
Glucose dynamics and insulin sensitivity
时间窗: 28 day treatment period
次要结局
未报告次要终点
研究者
研究点 (2)
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