This study will evaluate the safety and efficacy of a new combination of 3 (three) antihypertensive drugs in a single pill (candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg) compared with another combination of 3 (three) antihypertensive drugs (Exforge HCT® \[valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg\]). This will be a non-inferiority trial and the primary outcome will be blood pressure control after 12 weeks of treatment.
This phase III, multicenter, randomized, double-blind, controlled, parallel trial will evaluate the non-inferiority of the association between candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg in relation to Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12 5mg + amlodipine 5mg) in the treatment of systemic arterial hypertension. A total of 698 participants will be included. Follow-up visits will occur four, eight, and twelve weeks after the date of the randomization visit. A telephone contact will be performed 30 days after the end of treatment. The primary efficacy outcome is the mean change in blood pressure, measured at the research site, 12 weeks after starting treatment, compared to baseline. Incidence of adverse events will be collected from the first dose of treatment up to 30 days after the end of the treatment foreseen in the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
702
Antihypertensive drugs in a single tablet (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg)
Antihypertensive drugs in a single tablet (association valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Hospital de Urgência e Emergência de Rio Branco
Rio Branco, Acre, Brazil
Mean change in systolic blood pressure (SBP)
The primary efficacy endpoint is the mean change in systolic blood pressure, measured at the site, 12 weeks after starting treatment, compared to baseline.
Time frame: 12 weeks
Mean change in diastolic blood pressure (DBP)
Variation in diastolic blood pressure 4, 6 and 12 weeks after starting treatment
Time frame: 12 weeks
Participants with blood pressure (SBP <140 and DBP<90 mmHg)
Proportion of participants who reach the target blood pressure (SBP \<140 and DBP\<90mmHg) 4, 8 and 12 weeks after starting treatment
Time frame: 12 weeks
Participants with SBP <120 mmHg
Proportion of participants who reach the target blood pressure of SBP \<120 mmHg 4, 8 and 12 weeks after starting treatment
Time frame: 12 weeks
Participants with SBP <140 mmHg
Proportion of participants who reach target systolic blood pressure (SBP \<140 mmHg) 4, 8 and 12 weeks after starting treatment
Time frame: 12 weeks
Participants with DBP<90 mmHg
Proportion of participants who reach the target diastolic blood pressure (DBP\<90 mmHg) 4, 8 and 12 weeks after starting treatment
Time frame: 12 weeks
Participants with reduction greater than or equal to 20 mmHg in SBP
Proportion of participants who show a reduction greater than or equal to 20 mmHg in systolic blood pressure 4, 8 and 12 weeks after the start of treatment
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Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)
Maceió, Alagoas, Brazil
Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA
Fortaleza, Ceará, Brazil
Vitoria Clinical Research Institute LTDA
Vitória, Espírito Santo, Brazil
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Hospital Universitário Joao de Barros Barreto - UFPA
Belém, Pará, Brazil
Hospital 9 de Julho
São Paulo, Please Select, Brazil
Hospital Universitário Pedro Ernesto/UERJ
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto Atena de Pesquisa Clinica LTDA
Natal, Rio Grande do Norte, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
...and 12 more locations
Time frame: 12 weeks
Participants with reduction greater than or equal to 10 mmHg in DBP
Proportion of participants who have a reduction greater than or equal to 10 mmHg in diastolic blood pressure 4, 8 and 12 weeks after starting treatment
Time frame: 12 weeks