Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension
Condition: Arterial Hypertension
MeSH terms: Hypertension
Intervention: Fimasartan; Losartan
Intervention description: Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).
If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).
When possibilities are, the patient should be administrated by the study medication at the same time in the morning.; Cozaar® (Losartan), manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablets 50/100 mg
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung
      Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),
      manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult patients
      with Grade I-II arterial hypertension in 12 weeks of therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of both sex aged 18-75 inclusively.

          2. Subjects who signed their written Informed Consent for participation in the study and
             willing to adhere to all Protocol procedures.

          3. Subjects with documented diagnosis of grade I-II primary arterial hypertension within
             at least 3 months before screening.

          4. Systolic blood pressure (SBP) (when seated) at Screening (Day -14)

               -  For subjects administered with anti-hypertensive therapy: SBP ≤ 179 Hg

               -  For subjects receiving no anti-hypertensive therapy (so called 'naïve' patients):
                  140≥SBP ≤179.

          5. As per investigator's judgment, subjects with controlled arterial hypertension must
             benefit from the therapy switch to Kanarb (Fimasartan), manufactured by Boryung
             Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),
             manufactured by MERCK SHARP & DOHME B.V., Netherlands, .

          6. For subjects administered with anti-hypertensive drugs: the anti-hypertensive drug may
             be safely cancelled during the "wash-out" period according to the investigator's
             judgment.

          7. For women of child-bearing potential: negative urine pregnancy test at screening (Day
             -14). 8. Systolic blood pressure (SBP) (when seated) at Randomization (Day 0) ≥140
             mmHg and ≤179 mmHg.

        9. For women of child-bearing potential: negative urine pregnancy test at Randomization
        (Day 0)

        Exclusion Criteria:

          1. Grade III Arterial Hypertension.

          2. Arterial hypotension (SPB ≤100 mm Hg) at Screening (Day -14) and/or Randomization (Day
             0).

          3. Subjects needing treatment with more than one anti-hypertensive drug (more than one
             active substance, including complex drugs).

          4. Secondary (symptomatic) arterial hypertension.

          5. Known bilateral renal arterial stenosis or unilateral renal arterial stenosis.

          6. Hyperpotassemia >5,0 mmol/l (as per blood biochemistry results at Screening).

          7. Primary hyperaldosteronism.

          8. Known hypersensitivity to angiotensin-II receptors antagonists or any other study drug
             or comparator component.

          9. Contraindications for use of angiotensin-II receptors antagonists.

         10. Myocardial infarction and or unstable angina, and/or acute cerebrovascular
             accident/transient ischemic attack, and/or percutaneous coronary intervention, and/or
             coronary arterial bypass graft, acute coronary arteries involvement, and/or
             obliterative vascular atherosclerosis of low extremities, and/or grade III and IV
             retinopathy in anamnesis.

         11. Clinically significant cardiac valves damage.

         12. Cardiomyopathies

         13. Chronic Heart failure (CHF) (except for CHF FC I NYHA).

         14. Creatinine clearance less than 60 ml/min/1.73m2 calculated by Cockroft-Gault formula.

         15. Known moderate to severe hepatic insufficiency and/or transaminase increase: AST
             and/or ALT ≥2*ULN.

         16. History of infections (HIV, hepatitis B or C, syphilis).

         17. Uncontrolled Diabetes mellitus, Glycosylated hemoglobin level (HbA1c) >7%.

         18. Severe systemic diseases, such as gastro-intestinal tract diseases, autoimmune
             disorders, blood disorders and other conditions which may affect on the study drugs'
             absorption, distribution and and excretion.

         19. Clinically significant abnormalities of laboratory parameters.

         20. Drug or alcohol addiction, psychiatric disorders.

         21. Medical history of oncological disease within 5 years before screening.

         22. Subjects with biliary tracts obstruction.

         23. Subjects with genetic disorders, such as galactose intolerance, congenital lactase
             insufficiency and glucose-galaclose malabsorption syndrome.

         24. Any other acute disease or progression and/or decompensation at the moment of
             enrollment

         25. Necessity to administer or administration of prohibited concomitant drugs from the
             "List of Prohibited Drugs" within 14 days before enrollment

         26. Pregnancy or breast-feeding period; fertile women not using adequate contraception
             methods

         27. Participation in another clinical trial within 3 months before Screening.

         28. Other medical or psychiatric conditions or lab abnormalities that may increase
             potential risk associated with study participation and IP administration, or that may
             affect study results interpretation and as per investigator's judgment, make the
             subject ineligible.

         29. Study site personnel or Sponsor's representatives immediately involved in the study.

         30. Subjects, excluded from the study may not be included in it again.