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
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan
Valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Fimasartan, 24 hours ABP monitoring(ABPM), antihypertension
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fimasartan 30 mg
Valsartan 80 mg
Arm Description
Take one capsule filled with a Fimasartan 30 mg in the every morning
Take one capsule filled with a Valsartan 80 mg in the every morning
Outcomes
Primary Outcome Measures
Mean Systolic Blood Pressure during 24 hours
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
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
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
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
Trough-to-peak ratio
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
Smoothness index
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
Full Information
NCT ID
NCT01878201
First Posted
May 31, 2013
Last Updated
September 5, 2014
Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, Asan Medical Center, Seoul National University Bundang Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Inje University
1. Study Identification
Unique Protocol Identification Number
NCT01878201
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, Asan Medical Center, Seoul National University Bundang Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Inje University
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Fimasartan, 24 hours ABP monitoring(ABPM), antihypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fimasartan 30 mg
Arm Type
Experimental
Arm Description
Take one capsule filled with a Fimasartan 30 mg in the every morning
Arm Title
Valsartan 80 mg
Arm Type
Active Comparator
Arm Description
Take one capsule filled with a Valsartan 80 mg in the every morning
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Other Intervention Name(s)
Kanarb
Intervention Description
Fimasartan 30 mg
Intervention Type
Drug
Intervention Name(s)
Valsartan
Other Intervention Name(s)
Diovan
Intervention Description
Valsartan 80 mg
Primary Outcome Measure Information:
Title
Mean Systolic Blood Pressure during 24 hours
Description
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
Time Frame
8 weeks from baseline visit
Secondary Outcome Measure Information:
Title
Mean Diastolic Blood Pressure during 24 hours
Description
To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
Time Frame
8 weeks from baseline visit
Title
Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
Description
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
Time Frame
8 weeks from baseline visit
Title
Sitting Diastolic Blood pressure and Systolic Blood pressure
Description
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
Time Frame
8 weeks from baseline visit
Title
Trough-to-peak ratio
Description
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
Time Frame
8 weeks from baseline visit
Title
Smoothness index
Description
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
Time Frame
8 weeks from baseline visit
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
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.
Time Frame
about 10~11weeks from placebo run-in visit
Title
Adverse changes in laboratory test results
Description
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.)
Time Frame
about 10~11weeks from screening visit
Title
Adverse changes in electrocardiography(ECG)
Description
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.
Time Frame
about 10~11weeks from screening visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-He Oh, professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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