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

Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of three blood pressure medications taken in a single pill to see if it is as effective and safe as another existing medication combination. The new pill includes candesartan cilexetil, chlorthalidone, and amlodipine, while the comparison medication, Exforge HCT®, includes valsartan, hydrochlorothiazide, and amlodipine. The main goal is to find out how well these treatments control blood pressure over a period of 12 weeks.

To participate in this trial, you need to be at least 18 years old and currently taking two blood pressure medications that haven’t worked well for you. Your blood pressure must still be high despite treatment. You will have to agree to participate and sign a consent form. It's also important to note that certain health conditions, like severe kidney or liver problems, and recent heart issues, may prevent you from joining. If you decide to take part, you will have regular check-ups to monitor your health and blood pressure during the study. This trial is currently recruiting participants, so if you or someone you know is struggling with high blood pressure, this could be an option to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• Exclusion Criteria:
• • Any significant clinical condition that, in the investigator's opinion, may interfere with participant safety;
• • Any laboratory test finding 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;
• • Pregnant or breastfeeding women;
• • Women in a reproductive age who do not agree to use contraceptive methods;
• • 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;
• • 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;
• • Severe liver dysfunction;
• • Cardiogenic shock or reduced ejection fraction heart failure with a left ventricular ejection fraction less than or equal to 50%;
• • 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;
• • Clinically relevant ventricular cardiac arrhythmias;
• • Obstructive coronary artery disease planning percutaneous or surgical intervention;
• • Dementia syndrome;
• • History of alcohol or illicit drug addiction in the six months prior to the date of signature of the Informed Consent Form;
• • Obstructive biliary disorders;
• • Refractory hypokalemia and/or conditions involving marked potassium loss, hyperkalemia (\>5,5 mmol/L), and/or hyponatremia;
• • History of symptomatic hyperuricemia;
• • History of secondary hypertension;
• • History of cancer, without documentation of remission/cure;