NCT00562614已完成2 期
A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5 mg or 10 mg Once Daily for up to 14 Days in Patients With Hypertension
Response Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2007年6月1日最近更新:
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
- 38
- 试验地点
- 2
- 主要终点
- Peripheral systolic, diastolic blood pressures and heart rates
研究概览
简要总结
The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.
详细描述
- Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate
- 24 hour ambulatory blood pressure and heart rate
- Safety and tolerability
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 70 years old, inclusive
- •Moderate to severe hypertension
- •Body weight within a body mass index of 18-32kg/m2
排除标准
- •The subject is receiving more than three antihypertensive agents
- •A history of drug abuse
- •Exposure to a new chemical entity within 3 months prior to the first day of dosing
研究组 & 干预措施
1
Experimental
SLx-2101
干预措施: SLx-2101 (Drug)
2
Placebo Comparator
Comparative Placebo Dose
干预措施: SLx-2101 (Drug)
结局指标
主要结局
Peripheral systolic, diastolic blood pressures and heart rates
时间窗: 14 days
次要结局
- Adverse events(14 days)
研究者
研究点 (2)
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