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

Last updated: August 23, 2023
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Active - Recruiting

Phase

3

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

candesartan cilexetil + chlorthalidone + amlodipine

Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

Clinical Study ID

NCT05920005
LB2009
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Both genders aged 18 years or older;
  • Currently on dual antihypertensive therapy for at least 8 weeks, and non responders tothat treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/orDBP≥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

Exclusion Criteria:

  • Any significant clinical condition that, in the investigator's opinion, may interferewith participant safety;
  • Any laboratory test finding that, in the investigator's opinion, may interfere withparticipant safety;
  • Suspected or diagnosed with COVID 19;
  • History of hypersensitivity to components of drugs used during the trial or to drugsderived 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 theinvestigator 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 withcollaborators or employees of the Sponsor and the Research site;
  • Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated bythe Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or end-stagerenal disease;
  • Severe liver dysfunction;
  • Cardiogenic shock or reduced ejection fraction heart failure with a left ventricularejection fraction less than or equal to 50%;
  • Symptomatic congestive heart failure class II, III or IV, according to the New YorkHeart Association and/or participants with a history of infarction, unstable angina orcerebrovascular 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 ofsignature 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;

Study Design

Total Participants: 698
Treatment Group(s): 2
Primary Treatment: candesartan cilexetil + chlorthalidone + amlodipine
Phase: 3
Study Start date:
August 22, 2023
Estimated Completion Date:
July 01, 2024

Study Description

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.

Connect with a study center

  • Hospital de Urgência e Emergência de Rio Branco

    Rio Branco, AC
    Brazil

    Site Not Available

  • Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)

    Maceió, Alagoas
    Brazil

    Site Not Available

  • Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA

    Fortaleza, Ceará
    Brazil

    Site Not Available

  • Vitoria Clinical Research Institute LTDA

    Vitória, Espírito Santo
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Passos

    Passos, MG
    Brazil

    Site Not Available

  • Hospital Universitário Joao de Barros Barreto - UFPA

    Belém, Pará
    Brazil

    Site Not Available

  • Hospital 9 de Julho

    Sao Paulo, Please Select
    Brazil

    Site Not Available

  • Instituto Atena de Pesquisa Clinica LTDA

    Natal, Rio Grande Do Norte
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-007
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica do Coração

    Aracaju, SE
    Brazil

    Site Not Available

  • Hospital Universitário São Francisco de Assis

    Bragança Paulista, SP
    Brazil

    Active - Recruiting

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, SP
    Brazil

    Site Not Available

  • Hospital M'Boi Mirim

    São Paulo, SP
    Brazil

    Site Not Available

  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda

    Joinville, Santa Catarina
    Brazil

    Site Not Available

  • LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.

    Campinas, São Paulo
    Brazil

    Site Not Available

  • Indacor Serviços Médicos

    Indaiatuba, São Paulo
    Brazil

    Site Not Available

  • CIPES Centro Internacional de Pesquisa Clínica LTDA

    São José Dos Campos, São Paulo
    Brazil

    Site Not Available

  • Clínica Cardiológica

    Votuporanga, São Paulo
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo
    Brazil

    Site Not Available

  • Hospital Universitário Pedro Ernesto/UERJ

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Associação Lar São Francisco de Assis na Providência de Deus

    São Paulo,
    Brazil

    Site Not Available

  • InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

    São Paulo, 05403-900
    Brazil

    Site Not Available

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