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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

Phase 2
Completed
Conditions
Essential Hypertension
Interventions
Registration Number
NCT01878201
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Valsartan 80 mgValsartanTake one capsule filled with a Valsartan 80 mg in the every morning
Fimasartan 30 mgFimasartanTake one capsule filled with a Fimasartan 30 mg in the every morning
Primary Outcome Measures
NameTimeMethod
Mean Systolic Blood Pressure during 24 hours8 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
NameTimeMethod
Mean Diastolic Blood Pressure during 24 hours8 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 nighttime8 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 pressure8 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 ratio8 weeks from baseline visit

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

Smoothness index8 weeks from baseline visit

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

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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