Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension

Inclusion Criteria

• Subjects of both sex aged 18-75 inclusively.
• Subjects who signed their written Informed Consent for participation in the study and willing to adhere to all Protocol procedures.
• Subjects with documented diagnosis of grade I-II primary arterial hypertension within at least 3 months before screening.
• 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.
• 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, .
• 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.
• 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.
• For women of child-bearing potential: negative urine pregnancy test at Randomization (Day 0)

Exclusion Criteria

• Grade III Arterial Hypertension.
• Arterial hypotension (SPB ≤100 mm Hg) at Screening (Day -14) and/or Randomization (Day 0).
• Subjects needing treatment with more than one anti-hypertensive drug (more than one active substance, including complex drugs).
• Secondary (symptomatic) arterial hypertension.
• Known bilateral renal arterial stenosis or unilateral renal arterial stenosis.
• Hyperpotassemia >5, 0 mmol/l (as per blood biochemistry results at Screening).
• Primary hyperaldosteronism.
• Known hypersensitivity to angiotensin-II receptors antagonists or any other study drug or comparator component.
• Contraindications for use of angiotensin-II receptors antagonists.
• 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.
• Clinically significant cardiac valves damage.
• Cardiomyopathies
• Chronic Heart failure (CHF) (except for CHF FC I NYHA).
• Creatinine clearance less than 60 ml/min/1.73m2 calculated by Cockroft-Gault formula.
• Known moderate to severe hepatic insufficiency and/or transaminase increase: AST and/or ALT ≥2*ULN.
• History of infections (HIV, hepatitis B or C, syphilis).
• Uncontrolled Diabetes mellitus, Glycosylated hemoglobin level (HbA1c) >7%.
• 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.
• Clinically significant abnormalities of laboratory parameters.
• Drug or alcohol addiction, psychiatric disorders.
• Medical history of oncological disease within 5 years before screening.
• Subjects with biliary tracts obstruction.
• Subjects with genetic disorders, such as galactose intolerance, congenital lactase insufficiency and glucose-galaclose malabsorption syndrome.
• Any other acute disease or progression and/or decompensation at the moment of enrollment
• Necessity to administer or administration of prohibited concomitant drugs from the "List of Prohibited Drugs" within 14 days before enrollment
• Pregnancy or breast-feeding period; fertile women not using adequate contraception methods
• Participation in another clinical trial within 3 months before Screening.
• Other medical or psychiatric conditions or lab abnormalities that may increase potential risk associated