Hypertension
Conditions
Keywords
Fimasartan, Amlodipine, antihypertension
Brief summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
Interventions
DRUGFimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Sponsors
Gachon University Gil Medical Center
The Catholic University of Korea
Kyungpook National University Hospital
Daegu Catholic University Medical Center
Wonkwang University Hospital
Wonju Severance Christian Hospital
Korea University Guro Hospital
DongGuk University
Yeungnam University Hospital
Chonnam National University Hospital
Cheil General Hospital and Women's Healthcare Center
Chungnam National University
Asan Medical Center
Seoul National University Bundang Hospital
Inha University Hospital
Seoul National University Hospital
Inje University
Samsung Medical Center
Busan National University Yangsan Hospital
Soon Chun Hyang University
Catholic University of Korea Saint Paul's Hospital
Hallym University Kangnam Sacred Heart Hospital
Jeju National University Hospital
Hanyang University Seoul Hospital
Kangbuk Samsung Hospital
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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 90mmHg, 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.
Exclusion criteria
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 with sodium ion or body fluid is depleted and not able to correct 6. Patients with 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sitting Diastolic Blood Pressure | 8weeks from baseline visit | To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sitting Systolic Blood Pressure | at 4 and 8 weeks from Baseline visit | To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit |
| Sitting Diastolic Blood Pressure | 4weeks from baseline visit | To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit |
| Responder ratio | at 8weeks from baseline visit | To compare the ratio or responder(SiDBP\<90mmHg or difference of SiDBP\>10mmHg from baseline) at 8 weeks |
Countries
South Korea
Outcome results
None listed