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HypertensionPhase 3OPTION TREATNCT05920005

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

A Phase 3 study testing candesartan cilexetil + chlorthalidone + amlodipine and Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) in people with Hypertension, run by Hospital Israelita Albert Einstein at 22 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
candesartan cilexetil + chlorthalidone + amlodipine and Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
702 participants
Where
22 sitesBrazil
Study dates
22 Aug 2023to 1 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 22Show fewer
  • 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;
  • 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 (>5,5 mmol/L), and/or hyponatremia;
  • History of symptomatic hyperuricemia;
  • History of secondary hypertension;
  • History of cancer, without documentation of remission/cure;

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Brazil22 sites

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe

  • Hospital Universitário Joao de Barros Barreto - UFPA

    Belém, Pará

  • Hospital Universitário São Francisco de Assis

    Bragança Paulista, São Paulo

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo

  • LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.

    Campinas, São Paulo

  • Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA

    Fortaleza, Ceará

  • Indacor Serviços Médicos

    Indaiatuba, São Paulo

  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda

    Joinville, Santa Catarina

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

    Maceió, Alagoas

  • Instituto Atena de Pesquisa Clinica LTDA

    Natal, Rio Grande do Norte

  • Santa Casa de Misericórdia de Passos

    Passos, Minas Gerais

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-007

  • Hospital de Urgência e Emergência de Rio Branco

    Rio Branco, Acre

  • Hospital Universitário Pedro Ernesto/UERJ

    Rio de Janeiro, Rio de Janeiro

  • CIPES Centro Internacional de Pesquisa Clínica LTDA

    São José dos Campos, São Paulo

  • Hospital 9 de Julho

    São Paulo, Please Select

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

    São Paulo, São Paulo, 05403-900

  • Associação Lar São Francisco de Assis na Providência de Deus

    São Paulo, São Paulo

  • Hospital M'Boi Mirim

    São Paulo, São Paulo

  • Vitoria Clinical Research Institute LTDA

    Vitória, Espírito Santo

  • Clínica Cardiológica

    Votuporanga, São Paulo

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

About this study

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

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.

Read the detailed 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.

Conditions
Hypertension
Being tested
candesartan cilexetil + chlorthalidone + amlodipine, Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • candesartan cilexetil + chlorthalidone + amlodipineDrug

    Antihypertensive drugs in a single tablet (association 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)

Study groups in NCT05920005
Study groupRoleWhat they receive
Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mgExperimentalThe 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.
Receives: Drug: candesartan cilexetil + chlorthalidone + amlodipine
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)Active comparatorThe participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.
Receives: Drug: Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Mean change in diastolic blood pressure (DBP)

    Variation in diastolic blood pressure 4, 6 and 12 weeks after starting treatment

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  4. 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

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

  7. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start22 Aug 2023
  3. Primary completion31 Mar 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicenter, double-blind, phase III, parallel, controlled and randomized clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920005
Sponsor's protocol ID
LB2009
Acronym
OPTION TREAT
Status last verified
Jun 2023
First submitted
16 Jun 2023
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40892621

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing candesartan cilexetil + chlorthalidone + amlodipine and Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) in people with Hypertension, run by Hospital Israelita Albert Einstein at 22 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in systolic blood pressure (SBP) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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