NCT00562549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, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension
Response Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2007年7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
- 26
- 试验地点
- 1
- 主要终点
- Office seated peripheral systolic and diastolic blood pressure
研究概览
简要总结
The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.
详细描述
- Office seated peripheral systolic and diastolic blood pressure
- Adverse events and vital signs
- Plasma concentrations of SLx-2101
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females between 18 and 80 years, inclusive
- •Moderate to severe hypertension
- •Body weight within a body mass index range of 18 - 32 kg/m2
排除标准
- •Subject is receiving more than four antihypertensive agents
- •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
Matching Placebo Dose
干预措施: SLx-2101 (Drug)
结局指标
主要结局
Office seated peripheral systolic and diastolic blood pressure
时间窗: 12 days
次要结局
- Adverse events and changes in vital signs(12 days)
研究者
研究点 (1)
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