The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.

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

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Daegu Catholic University Medical Center; Dong-A medical center; Gyeongsang National University Hospital; Inje University; Keimyung University; Kosin University Gospel Hospital; Kyungpook National University; Kyungpook National University Hospital; Pusan National University Hospital; Pusan National University Yangsan Hospital; Ulsan University Hospital; Yeungnam University; Yeungnam University Hospital
• Treatments: Candesartan; Candesartan cilexetil

Criteria

Inclusion Criteria:

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

2. Subjects aged 19 to 75 years

3. Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)

2. Patients with secondary hypertension

3. Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication

4. Patients with hypotension who has sign and symptom

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

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

7. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)

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

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

10. Patients with severe cerebrovascular disease

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

12. Patients with known severe or malignancy retinopathy

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

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

15. 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

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

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

18. Childbearing and breast-feeding women

19. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods

20. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial

21. Subject who are judged unsuitable to participate in this study by investigator