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
- Registration Number
- NCT01518998
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with a placebo tablet in the every morning Amlodipine 10mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Amlodipine 10mg in the every morning Fimasartan 60mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with of Fimasartan 60mg in the every morning Fimasartan 30mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Fimasartan 30mg in the every morning Amlodipine 5mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Amlodipine 5mg in the every morning Fimasartan 60mg/ Amlodipine 5mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning Fimasartan 60mg/Amlodipine 10mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning Fimasartan 30mg/Amlodipine 5mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning Fimasartan 30mg/Amlodipine 10mg Fimasartan , Amlodipine, Placebo Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning
- Primary Outcome Measures
Name Time Method Sitting Diastolic Blood Pressure 8weeks from baseline visit To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of