New combination of antihypertensive drugs for high blood pressure

A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

This study is testing a new pill that combines three blood pressure medications to see if it works better than an existing option for people with high blood pressure.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Israelita Albert Einstein (Academic / other)
• Locations: 22 sites (Rio Branco, AC and 21 other locations)
• Trial ID: NCT05920005 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the safety and efficacy of a new combination of three antihypertensive medications (candesartan cilexetil, chlorthalidone, and amlodipine) in a single pill, compared to an existing combination (Exforge HCT®). The study is designed as a multicenter, randomized, double-blind, controlled trial involving 698 participants. The primary outcome is the change in blood pressure after 12 weeks of treatment, with follow-up visits at four, eight, and twelve weeks. Adverse events will also be monitored throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are currently on dual antihypertensive therapy but are not achieving adequate blood pressure control.

Not a fit: Patients with significant clinical conditions that may interfere with safety or those with a history of hypersensitivity to the trial medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient treatment option for patients with systemic arterial hypertension.

How similar studies have performed: Other studies have shown success with similar combinations of antihypertensive medications, indicating a promising approach to managing 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;

Where this trial is running

Rio Branco, AC and 21 other locations

• Hospital de Urgência e Emergência de Rio Branco — Rio Branco, Ac, Brazil (Not_yet_recruiting)
• Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas) — Maceió, Alagoas, Brazil (Not_yet_recruiting)
• Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA — Fortaleza, Ceará, Brazil (Not_yet_recruiting)
• Vitoria Clinical Research Institute LTDA — Vitória, Espírito Santo, Brazil (Not_yet_recruiting)
• Santa Casa de Misericórdia de Passos — Passos, Mg, Brazil (Not_yet_recruiting)
• Hospital Universitário Joao de Barros Barreto - UFPA — Belém, Pará, Brazil (Not_yet_recruiting)
• Hospital 9 de Julho — Sao Paulo, Please Select, Brazil (Not_yet_recruiting)
• Instituto Atena de Pesquisa Clinica LTDA — Natal, Rio Grande Do Norte, Brazil (Not_yet_recruiting)
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Not_yet_recruiting)
• CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda — Joinville, Santa Catarina, Brazil (Not_yet_recruiting)
• Centro de Pesquisa Clínica do Coração — Aracaju, Se, Brazil (Not_yet_recruiting)
• Hospital Universitário São Francisco de Assis — Bragança Paulista, Sp, Brazil (Recruiting)
• Instituto de Pesquisa Clínica de Campinas — Campinas, Sp, Brazil (Not_yet_recruiting)
• Hospital M'Boi Mirim — São Paulo, Sp, Brazil (Not_yet_recruiting)
• LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA. — Campinas, São Paulo, Brazil (Not_yet_recruiting)
• Indacor Serviços Médicos — Indaiatuba, São Paulo, Brazil (Not_yet_recruiting)
• CIPES Centro Internacional de Pesquisa Clínica LTDA — São José Dos Campos, São Paulo, Brazil (Not_yet_recruiting)
• Clínica Cardiológica — Votuporanga, São Paulo, Brazil (Not_yet_recruiting)
• Santa Casa de Misericordia de Votuporanga — Votuporanga, São Paulo, Brazil (Not_yet_recruiting)
• Hospital Universitário Pedro Ernesto/UERJ — Rio De Janeiro, Brazil (Not_yet_recruiting)
• InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP — São Paulo, Brazil (Not_yet_recruiting)
• Associação Lar São Francisco de Assis na Providência de Deus — São Paulo, Brazil (Not_yet_recruiting)

Study contacts

• Study coordinator: Vagner Madrini Junior, MD

Conditions Hypertension