NCT00626743已完成1 期
Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Maximal Change From Baseline in Standing SBP
研究概览
简要总结
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects 19-65 years of age inclusive
- •Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90 mmHg after more than 5 minutes in the supine position
- •Written informed consent
- •Willing and able to comply with the requirements of the protocol
排除标准
- •Subjects with acute or chronic disease within 4 weeks of study initiation.
- •Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
- •Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
- •Subjects with clinically significant abnormalities on laboratory tests
- •Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
- •Subjects with abnormal QTc interval(≥440ms)
- •Subjects with color-blindness or weakness
- •Subejcts with alcohol, drug or caffeine abuse
- •Diet known to alter drug absorption, distribution, metabolism or elimination processes
- •Subjects who participated in other clinical studies within 2 months before an administration
- •Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
研究组 & 干预措施
SK3530
Experimental
Active Drug
干预措施: SK3530 100mg, Placebo, Amlodipine (Drug)
Placebo
Placebo Comparator
Tablet which has the same appearance and taste but doesn't contain active ingredient
干预措施: SK3530 100mg, Placebo, Amlodipine (Drug)
结局指标
主要结局
Maximal Change From Baseline in Standing SBP
时间窗: within 8 hrs after SK3530 or placebo
次要结局
- Maximal Change From Baseline in Standing DBP(within 8 hrs after SK3530 or placebo)
研究者
研究点 (2)
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