Status:
COMPLETED
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
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Gachon University Gil Medical Center
The Catholic University of Korea
Conditions:
Hypertension
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
Eligibility Criteria
Inclusion
- Subjects who agreed to participate in this study and submitted the written informed consent
- Subjects aged 20 to 75 years
- Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
- Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.
Exclusion
- Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
- Patients with secondary hypertension
- 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
- Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- Patients with sodium ion or body fluid is depleted and not able to correct
- Patients with hypotension who has sign and symptom
- Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
- Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, regimen change of oral hypoglycemic agent, using insulin)
- Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
- Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
- Patients with severe cerebrovascular disease
- Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
- Patients with known severe or malignancy retinopathy
- Patients with hepatitis B or C or HIV positive reaction
- Patients who have a story or evidence of alcohol or drug abuse within 2years
- 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
- Patients with history of allergic reaction to any angiotensin II antagonist
- Patients with any chronic inflammation disease needed to chronic inflammation therapy
- Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- Childbearing and breast-feeding women
- Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
- Subject who are judged unsuitable to participate in this study by investigator
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01518998
Start Date
August 1 2011
End Date
November 1 2013
Last Update
July 1 2016
Active Locations (1)
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1
Samsung Medical Center
Seoul, Seoul, South Korea