Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

Prior treatment

• Symptomatic congestive heart failure class II, III or IV, according to the New York Heart Association and/or participants with a history of infarction, unstable angina or cerebrovascular accident in the last 6 months prior to the beginning of the study;
• History of alcohol or illicit drug addiction in the six months prior to the date of signature of the Informed Consent Form;

Other illness

• Any significant clinical condition that, in the investigator's opinion, may interfere with participant safety;
• Suspected or diagnosed with COVID 19;
• History of hypersensitivity to components of drugs used during the trial or to drugs derived from sulfonamides;
• Clinically relevant ventricular cardiac arrhythmias;
• Obstructive coronary artery disease planning percutaneous or surgical intervention;
• Dementia syndrome;
• Obstructive biliary disorders;
• History of symptomatic hyperuricemia;
• History of secondary hypertension;
• History of cancer, without documentation of remission/cure;

Lab values

• Any laboratory test finding that, in the investigator's opinion, may interfere with participant safety;
• Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) or end-stage renal disease;
• Cardiogenic shock or reduced ejection fraction heart failure with a left ventricular ejection fraction less than or equal to 50%;
• Refractory hypokalemia and/or conditions involving marked potassium loss, hyperkalemia (\>5,5 mmol/L), and/or hyponatremia;

Age

• Women in a reproductive age who do not agree to use contraceptive methods;

Other

• Pregnant or breastfeeding women;
• Male participants who do not agree to use contraceptive methods;
• Participation in clinical trial protocols in the last 12 (twelve) months, unless the investigator judges that there may be a direct benefit to the participant;
• Participant who has some kind of relationship up to the second degree or bond with collaborators or employees of the Sponsor and the Research site;
• Severe liver dysfunction;

• Both genders aged 18 years or older;
• Currently on dual antihypertensive therapy for at least 8 weeks, and non responders to that treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/or DBP≥90mmHg and ≤110 mmHg, assessed at the screening visit and randomization visit (both conditions are in accordance with the Brazilian Hypertension Guideline - 2020);
• Able to understand and consent to their participation in this clinical trial, manifested by signing the Informed Consent Form;