KCT0009705已完成Unknown
Efficacy and safety evaluation study of Oryeongsan for stage I primary hypertension: Multicenter randomized, double-blind, placebo-controlled, parallel design Investigator initiated exploratory clinical trials
Wonkwang University, Gwangju Medical Center0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Aged = 19 years old
- •2) Before Randomized, if either of the following applies
- •- 140 mmHg =MSSBP < 160 mmHg
- •- 90 mmHg = MSDBP < 100 mmHg
- •3) Those who are not currently taking anti-hypertensive medication and who have not taken medication for hypertension within the last 4 weeks
- •4) Those who have the ability and willingness to voluntarily agree to take part in the clinical trial and participate in the test
排除标准
- •1) At screening and randomized, MSSBP = 160 mmHg or MSDBP = 100 mmHg
- •2) At screening, SSBP difference is = 20 mmHg and SDBP difference= 10mmHg
- •3) Known or suspected secondary hypertension(ex. aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease)
- •4) Patients with orthostatic hypotension with symptoms
- •5) Unregulated diabetes (Excluding patients who do not need diabetes medication during the study period)
- •6) Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
- •7) Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- •8) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, immunologically significant aortic or mitral stenosis
- •9) Subject with severe cerebrovascular disease (infarct, hemorrage) ithin recent 6 months.
- •10) known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
- •11) Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
- •12) There is clinically significant kidney or liver disease defined by the following laboratory parameters:
- •- renal dysfunction(CCr < 30 mL/min, Serum creatinine = 2 mg/dL or UNL X 1.5)
- •- hepatic dysfunction(AST/ALT = UNL X 3)
- •13) Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
- •14) Patients who are dependent on drugs or alcohol
- •15) Childbearing and breast-feeding women, A female patient whose pregnancy was confirmed by a pregnancy test of urine specimen. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- •16) chronic inflammatory status need to treatment
- •17) Persons with known or suspected hypersensitivity reactions to the test substance or the same class of drug
- •18) Those who participated in other studies within 3 months before screening.
- •19) Those who drank on the day of study participation, those who consumed caffeine drinks within 1 hour
- •20) Subject who the opinion investigator make a judgment to be unsuitable for any other reason
研究者
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