KCT0000192招募中未知
A Randomized, Double-Blind, Placebo-Controlled, 3 x 3 factorial design, phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients with Essential Hypertension
Boryung Pharm0 个研究点目标入组 405 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 405
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. Subjects who agreed to participate in this study and submitted the written informed consent
- •2. Subjects aged 20 to 75 years
- •3. Essential hypertension subjects who are measured more 95mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
- •4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.
排除标准
- •1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
- •2. Patients with secondary hypertension
- •3. Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- •4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- •5. Patients witn sodium ion or body fluid is deplated and not able to correct
- •6. Patients with postural hypotension who has sign and symptom
- •7. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
- •8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
- •9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
- •10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- •11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
- •12. Patients with severe cerebrovascular disease
- •13. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
- •14. Patients with known severe or malignancy retinopathy
- •15. Patients with hepatitis B or C or HIV positive reaction
- •16. Patients who have a story or evidence of alcohol or drug abuse within 2years
- •17. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
- •18. Patients with history of allergic reaction to any angiotensin II antagonist
- •19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
- •20. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- •21. Childbearing and breast-feeding women
- •22. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- •23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
- •24. Subject who are judged unsuitable to participate in this study by investigator
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