A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Fimasartan 60 mg group; Fimasartan 120 mg group; Reference (Valsartan 80 mg) group
Intervention description: Fimasartan 60 mg; Fimasartan 120 mg; Reference (Valsartan 80 mg)
Intervention MeSH terms: Valsartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fimasartan; Essential Hypertension; 24hour ABPM; Population PK

Summary:

      The purpose of this study is to evaluate the antihypertensive efficacy and safety of
      Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate essential hypertension : sitting diastolic blood pressure measured at
             Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting
             diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg.

          -  Subjects who agree to participate in this sudy and give written informed consent

          -  Subjects considered to understand the study, be cooperative, and able to be
             followed-up until the end of the study

        Exclusion Criteria:

          -  The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive
             patient with sitting systolic blood pressure over 200mmHg Patients with secondary
             hypertension

          -  Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological
             or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which
             might affect absorption, disposition, metabolism or excretion of the drug

          -  Patients with postural hypotension

          -  Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes
             mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated
             insulin before screening)

          -  Patients with a history of myocardial infarction, severe coronary artery disease or
             clinically significant heart failure or valvular defect in last 6 months

          -  Patients with consumptive disease, autoimmune disease, connective tissue disease

          -  Patients with a history of type B or C hepatitis

          -  Patients with HIV or hepatitis

          -  Patients with clinically significant laboratory abnormality

          -  Patients receiving any drugs known to affect blood pressure or medical treatments that
             can influence the blood pressure

          -  Patients with allergy or contraindication to any angiotensin II receptor antagonists

          -  Female of childbearing potential who does not undergo hysterectomy or is not
             post-menopausal

          -  Patients judged to have a history of alcohol or drug abuse by the investigator

          -  Patients participated other clinical trial 12 weeks before Screening Patients judged
             to be inappropriate for this study by the investigator with other reasons