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Completed

NCT Number: NCT01878201

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

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fimasartan

Drug

Fimasartan 30 mg

Other names: Kanarb

valsartan

Drug

Valsartan 80 mg

Other names: Diovan

Primary outcomes

  1. Mean Systolic Blood Pressure during 24 hours

    Time frame: 8 weeks from baseline visit

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

Secondary outcomes

  1. Mean Diastolic Blood Pressure during 24 hours

    Time frame: 8 weeks from baseline visit

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

  2. Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime

    Time frame: 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

  3. Sitting Diastolic Blood pressure and Systolic Blood pressure

    Time frame: 8 weeks from baseline visit

    To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit

  4. Trough-to-peak ratio

    Time frame: 8 weeks from baseline visit

    Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor

  5. Smoothness index

    Time frame: 8 weeks from baseline visit

    Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor

Other outcomes

  1. Adverse events

    Time frame: 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.

  2. Adverse changes in laboratory test results

    Time frame: 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.)

  3. Adverse changes in electrocardiography(ECG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Collaborators

  • Asan Medical Center
  • Chonnam National University Hospital
  • Inje University
  • Kyungpook National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2013
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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