A phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients with Essential Hypertensio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0000192
- Lead Sponsor
- Boryung Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 405
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (AE, Investigations, Body weight, Pulse rate);Sitting Diastolic Blood Pressure
- Secondary Outcome Measures
Name Time Method Sitting Systolic Blood Pressure;Sitting Diastolic Blood Pressure;Responder ratio