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

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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Fimasartan; Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects aged 20 to 70 years
2. 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)
3. Subjects who agreed to participate in this study and submitted the written informed consent
4. Subjects who considered to understand this study, be cooperative, and able to be followed-up whole of the study period

Exclusion Criteria:

1. 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)
2. Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
3. Patients with secondary hypertension
4. Patients with symptomatic orthostatic hypotension
5. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
6. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
7. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
8. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
9. Patients with severe cerebrovascular disease within 6 months
10. Patients with known severe or malignancy retinopathy within 6 months
11. Patients with wasting disease, autoimmune disease, connective tissue disease
12. 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)
13. Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
14. Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
15. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
16. Patients with depletion of body fluid or sodium ion not able to correct
17. Patients with suspected or history of drug or alcohol abuse within the past two years
18. 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
19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
20. Patients with hepatitis type B or type C and carriers
21. Patients with laboratory test results indicating clinically significant abnormal results
22. Patients receiving medication that can affect blood pressure
23. Patients with history of allergic reaction to any angiotensin II antagonist
24. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
25. Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
26. Subject who are judged unsuitable to participate in this study by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks from baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	8 weeks from baseline visit
Smoothness index	Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor	8 weeks from baseline visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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.	about 10~11weeks from placebo run-in visit
Adverse changes in laboratory test results	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.)	about 10~11weeks from screening visit
Adverse changes in electrocardiography(ECG)	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.	about 10~11weeks from screening visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Asan Medical Center; Chonnam National University Hospital; Seoul National University Hospital; Seoul National University Bundang Hospital; Kyungpook National University Hospital; Inje University
• Investigators: Study Chair: Byung-He Oh, professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 31, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Fimasartan; antihypertension; 24 hours ABP monitoring(ABPM)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: A657-BR-CT-L201