A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Asan Medical Center; Busan National University Yangsan Hospital; Catholic University of Korea Saint Paul's Hospital; Cheil General Hospital and Women's Healthcare Center; Cheil General Hospital and Women’s Healthcare Center; Chonnam National University Hospital; Chungnam National University; Daegu Catholic University Medical Center; DongGuk University; Gachon University Gil Medical Center; Hallym University Kangnam Sacred Heart Hospital; Hanyang University Seoul Hospital; Inha University Hospital; Inje University; Jeju National University Hospital; Kangbuk Samsung Hospital; Korea University Guro Hospital; Kyungpook National University; Kyungpook National University Hospital; Samsung Medical Center; Seoul National University Bundang Hospital; Seoul National University Hospital; Soon Chun Hyang University; The Catholic University of Korea; Wonju Severance Christian Hospital; Wonkwang University Hospital; Yeungnam University; Yeungnam University Hospital
• Treatments: Amlodipine

Criteria

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