A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of... | NCT01518998 | Trialant
CompletedInterventionalPhase 2Updated Jul 1, 2016
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
ClinicalTrials.gov ID
NCT01518998
Lead Sponsor
Boryung Pharmaceutical Co., LtdINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
420Actual
Last Update Posted
Jul 1, 2016Estimated
Start Date
Aug 2011
Primary Completion Date
Oct 2013Actual
Completion Date
Nov 2013Actual
Brief Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
Hypertension
Fimasartan , Amlodipine, Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Factorial Assignment
Masking
Double
No central contacts
There are no central contacts for this study.
Samsung Medical Center
Seoul, Seoul, South Korea
Lead Sponsor
Boryung Pharmaceutical Co., LtdINDUSTRY
Collaborators
Gachon University Gil Medical CenterOTHER
The Catholic University of KoreaOTHER
Kyungpook National University HospitalOTHER
Daegu Catholic University Medical CenterOTHER
Wonkwang University HospitalOTHER
Wonju Severance Christian HospitalOTHER
Korea University Guro HospitalOTHER
DongGuk UniversityOTHER
Yeungnam University HospitalOTHER
Chonnam National University HospitalOTHER
Cheil General Hospital and Women's Healthcare CenterOTHER
Chungnam National UniversityOTHER
Asan Medical CenterOTHER
Seoul National University Bundang HospitalOTHER
Inha University HospitalOTHER
Seoul National University HospitalOTHER
Inje UniversityOTHER
Samsung Medical CenterOTHER
Busan National University Yangsan HospitalUNKNOWN
Soon Chun Hyang UniversityOTHER
Catholic University of Korea Saint Paul's HospitalOTHER
Hallym University Kangnam Sacred Heart HospitalOTHER