Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05920005
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05920005
Study Brief:
Protocol Section:
NCT05920005