A Randomized, Double-Blind, Placebo-Controlled, 3x3 Facto... | NCT01518998

Status Module

Name	Class
Gachon University Gil Medical Center	OTHER
The Catholic University of Korea	OTHER
Kyungpook National University Hospital	OTHER
Daegu Catholic University Medical Center

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Take one double-blind capsule filled with a placebo tablet in the every morning	Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg	Active Comparator	Take one double-blind capsule filled with of Fimasartan 60mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 30mg	Active Comparator	Take one double-blind capsule filled with Fimasartan 30mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo
Amlodipine 5mg	Active Comparator	Take one double-blind capsule filled with Amlodipine 5mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo
Amlodipine 10mg	Active Comparator	Take one double-blind capsule filled with Amlodipine 10mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg/ Amlodipine 5mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fimasartan , Amlodipine, Placebo	Drug	Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination

Measure	Description	Time Frame
Sitting Diastolic Blood Pressure	To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit	8weeks from baseline visit

Measure	Description	Time Frame
Sitting Systolic Blood Pressure	To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit	at 4 and 8 weeks from Baseline visit
Sitting Diastolic Blood Pressure

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Young Kwan Jeon, Medical Director	Boryung Pharmaceutical Co., Ltd	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Seoul		South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25850881	Derived	Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
C558933	fimasartan
D017311	Amlodipine

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds