Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension

Exclusion Criteria

• •Severe hypertension (Grade 3), with SBP≥180 mmHg and/or DBP≥110 mmHg, according to OFFICIAL MEXICAN NORM NOM 030-SSA criteria.
• •Secondary hypertension.
• •Impossibility to safely undergo a two week washout period from previous treatment prior to assignment to the study treatment, if applicable and according to the principal investigator´s judgment.
• •Systemic diseases such as renal dysfunction (creatinine ≥1.5 time above the upper limit of the reference range), gastrointestinal disorders, hematological disorders or liver dysfunction (AST y/o ALT ≥1.5 times the upper limit of the reference range), capable to affect the absorption, distribution, metabolism and excretion of the study drug.
• •Non-controlled diabetes mellitus (HbA1c\>9%)
• •Morbid obesity (BMI≥40 kg/m2)
• •Myocardial infarction or severe coronary artery disease or clinically significant congestive heart failure, within the six months prior to the screening visit.
• •Auto-immune or connective tissue disease.
• •Evidence in the medical record of serious infectious diseases such as hepatitis type B or C or a positive HIV test at screening.
• •Clinically significant laboratory test abnormalities, according to the investigator's judgment.
• •Concomitant treatment which might affect blood pressure values.
• •Known allergies or contraindication to the use of angiotensin II receptor antagonists.
• •Pregnancy, breastfeeding or in the case of women with childbearing potential, the rejection to use an effective contraceptive method, according to the investigator's judgment.
• •History of alcohol or addictive substance abuse.
• •Subjects participating in other clinical studies or who have participated in other study within the 6 months prior to screening.
• •Any other reason which in the investigator's opinion might contraindicate the participation of a subject in the study.