Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (OPTION TREAT)
Hypertension
About this trial
This is an interventional treatment trial for Hypertension
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; 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, and/or hyponatremia; History of symptomatic hyperuricemia; History of secondary hypertension; History of cancer, without documentation of remission/cure;
Sites / Locations
- Hospital de Urgência e Emergência de Rio Branco
- Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)
- Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA
- Vitoria Clinical Research Institute LTDA
- Santa Casa de Misericórdia de Passos
- Hospital Universitário Joao de Barros Barreto - UFPA
- Hospital 9 de Julho
- Instituto Atena de Pesquisa Clinica LTDA
- Hospital de Clínicas de Porto Alegre
- CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
- Centro de Pesquisa Clínica do Coração
- Hospital Universitário São Francisco de AssisRecruiting
- Instituto de Pesquisa Clínica de Campinas
- Hospital M'Boi Mirim
- LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.
- Indacor Serviços Médicos
- CIPES Centro Internacional de Pesquisa Clínica LTDA
- Clínica Cardiológica
- Santa Casa de Misericordia de Votuporanga
- Hospital Universitário Pedro Ernesto/UERJ
- InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
- Associação Lar São Francisco de Assis na Providência de Deus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
The participant will take, once a day, 01 tablet of the active experimental drug (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg), plus 01 placebo, both orally.
The participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.