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

NCT05920005 | Completed Phase 3 DMC

• 1 other identifier: LB2009
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Mean change in diastolic blood pressure (DBP)

  12 weeks

• Participants with blood pressure (SBP <140 and DBP<90 mmHg)

  12 weeks

• Participants with SBP <120 mmHg

  12 weeks

• Participants with SBP <140 mmHg

  12 weeks

• Participants with DBP<90 mmHg

  12 weeks

Study Arms (2)

Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg

EXPERIMENTAL

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.

Drug: candesartan cilexetil + chlorthalidone + amlodipine

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

ACTIVE COMPARATOR

The participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.

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

Interventions

candesartan cilexetil + chlorthalidone + amlodipine DRUG

Antihypertensive drugs in a single tablet (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg)

Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg

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

Antihypertensive drugs in a single tablet (association valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Libbs Farmacêutica LTDA: collaborator

Study Sites (22)

Hospital de Urgência e Emergência de Rio Branco

Rio Branco, Acre, Brazil

Location

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

Maceió, Alagoas, Brazil

Location

Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA

Fortaleza, Ceará, Brazil

Location

Vitoria Clinical Research Institute LTDA

Vitória, Espírito Santo, Brazil

Location

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

Location

Hospital Universitário Joao de Barros Barreto - UFPA

Belém, Pará, Brazil

Location

Hospital 9 de Julho

São Paulo, Please Select, Brazil

Location

Hospital Universitário Pedro Ernesto/UERJ

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Instituto Atena de Pesquisa Clinica LTDA

Natal, Rio Grande do Norte, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda

Joinville, Santa Catarina, Brazil

Location

Centro de Pesquisa Clínica do Coração

Aracaju, Sergipe, Brazil

Location

Hospital Universitário São Francisco de Assis

Bragança Paulista, São Paulo, Brazil

Location

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, Brazil

Location

LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.

Campinas, São Paulo, Brazil

Location

Indacor Serviços Médicos

Indaiatuba, São Paulo, Brazil

Location

CIPES Centro Internacional de Pesquisa Clínica LTDA

São José dos Campos, São Paulo, Brazil

Location

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

São Paulo, São Paulo, 05403-900, Brazil

Location

Associação Lar São Francisco de Assis na Providência de Deus

São Paulo, São Paulo, Brazil

Location

Hospital M'Boi Mirim

São Paulo, São Paulo, Brazil

Location

Clínica Cardiológica

Votuporanga, São Paulo, Brazil

Location

Santa Casa de Misericordia de Votuporanga

Votuporanga, São Paulo, Brazil

Location

Related Publications (1)

• Madrini V Jr, Tavares CAM, Albuquerque MTA, Silvestre OM, Felicio JS, Silveira FS, Hissa MN, Antunes MO, Mota-Gomes MA, Vidotti MH, Fuchs FD, Marcondes-Braga FG, Filho CRH, Troiani do Nascimento C, Bastos RA, Brandao AA, Cestario EES, Bortolotto LA, Castilho VC, Lapa MG, Magaton EAP, Fernandes PB, Albuquerque CSN, Silva LR, Berwanger O, Guimaraes PO. Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension: The OPTION TREAT Trial. JACC Adv. 2025 Oct;4(10 Pt 2):102175. doi: 10.1016/j.jacadv.2025.102175. Epub 2025 Aug 29.

  PMID: 40892621 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil; Chlorthalidone; Amlodipine; Exforge HCT; Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Thiazides

Study Officials

• Patrícia Oliveira Guimarães, MD, PhD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The experimental/comparator drug has different characteristics. To allow blinding, the Double-Dummy method will be performed, where study sites will receive two drug presentations (active and placebo), thus preventing any violation of blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, double-blind, phase III, parallel, controlled and randomized clinical trial.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: August 22, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (22)