A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Asan Medical Center; Bucheon St. Mary's Hospital; Daegu Fatima Hospital; Dong-A University; Ewha Womans University Mokdong Hospital; Gangnam Severance Hospital; Hallym University Medical Center; Hanyang University; Jeju National University Hospital; Kangbuk Samsung Hospital; Konyang University Hospital; Korea University Anam Hospital; National Health Insurance Service Ilsan Hospital; Sejong General Hospital; Severance Hospital; Soon Chun Hyang University; Ulsan University Hospital
• Treatments: Antihypertensive Agents; Valsartan

Criteria

Inclusion Criteria:

1. Subjects who agreed to participate in this clinical trial and submitted the written informed consent

2. Subjects aged 20 to 75 years

3. Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)

4. Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

Exclusion Criteria:

1. Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)

2. Patients with orthostatic hypotension who has sign and symptom

3. Patients with secondary hypertension

4. Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit

5. Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs

6. 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 limit of normal), severe fatty liver disease needed medication

7. Patients with clinically significant investigations in laboratory test of screening visit

8. Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion

9. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)

10. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)

11. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia

12. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease

13. Patients with severe cerebrovascular disease

14. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous

15. Patients with known severe or malignancy retinopathy

16. Patients with hepatitis B or C or HIV positive reaction

17. Patients with the medical histories of malignant tumor within 5 years,except local basal cell carcinoma of the skin

18. Patients who have a story or evidence of alcohol or drug abuse within 2 years

19. Patients with history of allergic reaction to any angiotensin II antagonist

20. Patients with any chronic inflammation disease needed to chronic inflammation therapy

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. Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L), Hyperkalemia(exceeded 5.5 mmol/L)

25. Patients with sodium ion or body fluid is deplated and not able to correct

26. Subject who are judged unsuitable to participate in this clinical trial by investigator