A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01878201

Collaborator

Seoul National University Hospital (Other), Asan Medical Center (Other), Seoul National University Bundang Hospital (Other), Kyungpook National University Hospital (Other), Chonnam National University Hospital (Other), Inje University (Other)

Enrollment

Location

Arms

9.1

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Fimasartan Drug: Valsartan	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fimasartan 30 mg Take one capsule filled with a Fimasartan 30 mg in the every morning	Drug: Fimasartan Fimasartan 30 mg Other Names: Kanarb
Active Comparator: Valsartan 80 mg Take one capsule filled with a Valsartan 80 mg in the every morning	Drug: Valsartan Valsartan 80 mg Other Names: Diovan

Arm

Intervention/Treatment

Experimental: Fimasartan 30 mg

Take one capsule filled with a Fimasartan 30 mg in the every morning

Drug: Fimasartan

Fimasartan 30 mg

Other Names:

Kanarb

Active Comparator: Valsartan 80 mg

Take one capsule filled with a Valsartan 80 mg in the every morning

Drug: Valsartan

Valsartan 80 mg

Other Names:

Diovan

Outcome Measures

Primary Outcome Measures

Mean Systolic Blood Pressure during 24 hours [8 weeks from baseline visit]
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit

Secondary Outcome Measures

Mean Diastolic Blood Pressure during 24 hours [8 weeks from baseline visit]
To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime [8 weeks from baseline visit]
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
Sitting Diastolic Blood pressure and Systolic Blood pressure [8 weeks from baseline visit]
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
Trough-to-peak ratio [8 weeks from baseline visit]
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
Smoothness index [8 weeks from baseline visit]
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor

Other Outcome Measures

Adverse events [about 10~11weeks from placebo run-in visit]
Adverse evnt(AE)s are collected as a safety measure. All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.
Adverse changes in laboratory test results [about 10~11weeks from screening visit]
Adverse changes in laboratory test results are collected as a safety measure. As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)
Adverse changes in electrocardiography(ECG) [about 10~11weeks from screening visit]
Adverse changes in ECG are collected as a safety measure. As a categorical data, adverse changes in ECG present frequency and percentage for each category.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects aged 20 to 70 years
Essential hypertension subjects who are measured more 135/85 mmHg of average Diastolic Blood pressure (DBP) and Systolic Blood pressure (SBP) measured by ABP monitor at baseline visit(day 0)
Subjects who agreed to participate in this study and submitted the written informed consent
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 180 mmHg of mean sitting SBP and/or more 110 mmHg of mean sitting DBP measured as an office Blood pressure (BP), before Randomization (Screening visit, Placebo run-in visit, Pre-Baseline visit, Baseline visit)
Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
Patients with secondary hypertension
Patients with symptomatic orthostatic hypotension
Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
Patients with severe heart disease, ischemic heart disease within 6 months, 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 within 6 months
Patients with known severe or malignancy retinopathy within 6 months
Patients with wasting disease, autoimmune disease, connective tissue disease
Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (Aspartate Transaminase(AST), Alanine Transaminase(ALT) more 2 times than upper normal)
Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
Patients with depletion of body fluid or sodium ion not able to correct
Patients with suspected or history of drug or alcohol abuse within the past two years
Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
Patients with any chronic inflammation disease needed to chronic inflammation therapy
Patients with hepatitis type B or type C and carriers
Patients with laboratory test results indicating clinically significant abnormal results
Patients receiving medication that can affect blood pressure
Patients with history of allergic reaction to any angiotensin II antagonist
Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
Patients who took investigational drug 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