Essential Arterial HypertensionPhase 3NCT04927299

Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial Hypertension

A Phase 3 study testing Losartan/Chlorthalidone in fixed dose and Losartan + hydrochlorothiazide in fixed dose in people with Essential Arterial Hypertension, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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

Phase IIIb, randomized, double-blind, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination of losartan / chlorthalidone compared with losartan / hydrochlorothiazide in the treatment of patients with essential arterial hypertension. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Essential Arterial Hypertension
What is being tested?: Losartan/Chlorthalidone in fixed dose and Losartan + hydrochlorothiazide in fixed dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteMexico
Study dates: 30 Jun 2022to 11 Sep 2023
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Any sex.
That they agree to participate in the study and give their informed consent in writing.
Age between 18 and 65 years old at the beginning of the study.
Patients with essential arterial hypertension with BP ≥140 / 90 mmHg and <180/110 mmHg.
Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal), menopausal or surgically sterile.

Who cannot join

The drug is contraindicated for medical reasons.
Glomerular filtration rate ≤30 ml / min x 1.73 m2.
Hypersensitivity to any of the components of the formula or other sulfonamides.
Patients treated with other diuretics.
Patient with a history of vascular disease (cerebrovascular disease, acute coronary syndrome, etc.) and acute renal failure in the last 6 months.
Patient with severe complications of type 2 diabetes mellitus (Ketoacidosis or hyperosmolar nonketotic coma).

Show all 11Show fewer

Patients participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.
Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
Patients diagnosed with gout.
Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000

Other trials in Mexico

About this study

Official title: Confirmatory Study of the Efficacy and Safety of the Combination of Losartan / Chlorthalidone vs Losartan / Hydrochlorothiazide in the Treatment of Patients With Essential Arterial Hypertension

Read the detailed description

Two groups of patients will be formed, who wil start treatment with the lower dose (Losartan 50 mg + chlorthalidone 12.5 mg; Losartan 50 mg + hydrochlorothiazide 12.5 mg).

Blood pressure (BP) figures will be evaluated and, in those patients who do not reach the therapeutic goal, defined as a decrease in Systolic blood pressure (SBP) / Diastolic blood pressure (DBP) values of 20/10 mmHg with respect to their baseline values or BP <140 / 90 mmHg, the dose will be escalated to the next available concentration for both treatments (Losartan 100 mg + chlorthalidone 25 mg; Losartan 100 mg + hydrochlorothiazide 25 mg) at 30 days or during an unscheduled visit.

After two months of treatment, the BP figures obtained with the final dose and the proportion of subjects who achieved a decrease in SBP / DBP values of 20/10 mmHg or <140/90 mmHg with respect to both combinations will be compared, and the frequency of adverse events presented will be described.

Conditions: Essential Arterial Hypertension
Being tested: Losartan/Chlorthalidone in fixed dose, Losartan + hydrochlorothiazide in fixed dose
Keywords: Hypertension, Blood pressure, Diuretic, Losartan, Chlorthalidone
Medical subject headings: Hypertension

What participants receive

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

Losartan/Chlorthalidone in fixed doseDrug
Also called LOS/CHLORTHA
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Losartan + hydrochlorothiazide in fixed doseDrug
Also called LOS/HYDROCHLO
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg

Study groups in NCT04927299
Study group	Role	What they receive
Group A: Losartan + chlorthalidone	Experimental	Administered orally, one tablet a day, for 2 months. Receives: Drug: Losartan/Chlorthalidone in fixed dose
Group B: Losartan + hydrochlorothiazide	Active comparator	Administered orally, one tablet a day, for 2 months. Receives: Drug: Losartan + hydrochlorothiazide in fixed dose

What is being measured

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

Change in systolic blood pressure (SBP)
Evaluate the mean change in systolic blood pressure (SBP) at 2 months with respect to their baseline measurement, by treatment group with the final dose.
Measured: Baseline and 2 months
Change in diastolic blood pressure (DBP)
Evaluate the mean change in diastolic blood pressure (DBP) at 2 months with respect to their baseline measurement, by treatment group with the final dose.
Measured: Baseline and 2 months

Secondary outcomes (4)

Dosage adjustment requirement
Describe the proportion of subjects who required dose adjustment per treatment group.
Measured: 2 months
Subjects who achieved blood pressure reduction goals
Proportion of subjects who decreased their systolic pressure by 20 mmHg and their diastolic pressure by 10 mmHg from baseline or blood pressure <140/90 mmHg per treatment group with the final dose.
Measured: 2 months
Percentage of adherence to treatment
Assess the percentage of adherence to treatment during the intervention, by pill count.
Measured: 2 months
Adverse events
Describe the frequency and intensity of adverse events and adverse reactions presented during the study by treatment group.
Measured: 2 months

Timeline

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

30 Jun 202211 Sep 2023

First posted15 Jun 2021
Study start30 Jun 2022
Primary completion15 Aug 2023
Study completion11 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Essential Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927299
Sponsor's protocol ID: SIL-30601-III-20(1)
Status last verified: Mar 2025
First submitted: 8 Jun 2021
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
PubMed 29133356
Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.
PubMed 15652604
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199
Morales-Salinas A, Wyss F, Coca A, Ramirez AJ, Valdez O, Valerio LF. [Differences between the 2013 and 2014 hypertension guidelines.: Position of the Central American and Caribbean Society for Hypertension and Cardiovascular Prevention]. Rev Panam Salud Publica. 2015 Mar;37(3):172-8. Spanish.
PubMed 25988254
2018 ESC/ESH Guidelines for the management of arterial hypertension. Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):160. doi: 10.1016/j.rec.2018.12.004. No abstract available. English, Spanish.
PubMed 30704723
Gonzalez-Juanatey JR, Mazon Ramos P. Cardiovascular prevention (VI). Use of drugs in the primary prevention of arterial hypertension and dyslipidemia. Rev Esp Cardiol. 2008 Aug;61(8):861-79. English, Spanish.
PubMed 18684369
ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
PubMed 20228401
Guerrero-Garcia C, Rubio-Guerra AF. Combination therapy in the treatment of hypertension. Drugs Context. 2018 Jun 6;7:212531. doi: 10.7573/dic.212531. eCollection 2018.
PubMed 29899755
Ernst ME, Moser M. Use of diuretics in patients with hypertension. N Engl J Med. 2009 Nov 26;361(22):2153-64. doi: 10.1056/NEJMra0907219. No abstract available.
PubMed 19940300
Kurtz TW, Klein U. Next generation multifunctional angiotensin receptor blockers. Hypertens Res. 2009 Oct;32(10):826-34. doi: 10.1038/hr.2009.135. Epub 2009 Aug 28.
PubMed 19713966
Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
PubMed 32370572
Rucker-Joerg IE, Cardona-Munoz EG, Padilla-Padilla FG, Suarez-Otero R, Romero-Antonio Y, Canales-Vazquez E, Rios-Brito KF, Rodriguez-Vazquez IC, Gonzalez-Canudas J. Optimizing Blood Pressure Control: A Randomized Comparative Trial of Losartan/Chlorthalidone vs. Losartan/Hydrochlorothiazide. Cardiol Ther. 2025 Jun;14(2):231-247. doi: 10.1007/s40119-025-00407-7. Epub 2025 Apr 24.
PubMed 40274695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Essential Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Confirmatory Study of the Efficacy and Safety of the Combination of Losartan / Chlorthalidone vs Losartan / Hydrochlorothiazide in the Treatment of Patients With Essential Arterial Hypertension
ClinicalTrials.gov ID: NCT04927299
Acronym / sponsor ID: SIL-30601-III-20(1)
Conditions: Essential Arterial Hypertension
Keywords: Hypertension, Blood pressure, Diuretic, Losartan, Chlorthalidone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 30 Jun 2022 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 11 Sep 2023 (actual)
First posted: 15 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Two groups of patients will be formed, who wil start treatment with the lower dose (Losartan 50 mg + chlorthalidone 12.5 mg; Losartan 50 mg + hydrochlorothiazide 12.5 mg).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A: Losartan + chlorthalidone	Experimental	Drug: Losartan/Chlorthalidone in fixed doseAdministered orally, one tablet a day, for 2 months.
Group B: Losartan + hydrochlorothiazide	Active comparator	Drug: Losartan + hydrochlorothiazide in fixed doseAdministered orally, one tablet a day, for 2 months.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Any sex.
That they agree to participate in the study and give their informed consent in writing.
Age between 18 and 65 years old at the beginning of the study.
Patients with essential arterial hypertension with BP ≥140 / 90 mmHg and <180/110 mmHg.
Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal), menopausal or surgically sterile.

Key exclusion criteria (11 listed)

The drug is contraindicated for medical reasons.
Glomerular filtration rate ≤30 ml / min x 1.73 m2.
Hypersensitivity to any of the components of the formula or other sulfonamides.
Patients treated with other diuretics.
Patient with a history of vascular disease (cerebrovascular disease, acute coronary syndrome, etc.) and acute renal failure in the last 6 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Losartan/Chlorthalidone in fixed doseAlso: LOS/CHLORTHA1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg	Drug	Group A: Losartan + chlorthalidone
Losartan + hydrochlorothiazide in fixed doseAlso: LOS/HYDROCHLO1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg	Drug	Group B: Losartan + hydrochlorothiazide

Primary outcome

Change in systolic blood pressure (SBP)
Time frame: Baseline and 2 months
Evaluate the mean change in systolic blood pressure (SBP) at 2 months with respect to their baseline measurement, by treatment group with the final dose.
Change in diastolic blood pressure (DBP)
Time frame: Baseline and 2 months
Evaluate the mean change in diastolic blood pressure (DBP) at 2 months with respect to their baseline measurement, by treatment group with the final dose.

4 secondary outcomes

Dosage adjustment requirement
Time frame: 2 months
Subjects who achieved blood pressure reduction goals
Time frame: 2 months
Percentage of adherence to treatment
Time frame: 2 months
Adverse events
Time frame: 2 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Background: PubMed 29133356Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
Background: PubMed 15652604Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.
Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
Background: PubMed 25988254Morales-Salinas A, Wyss F, Coca A, Ramirez AJ, Valdez O, Valerio LF. [Differences between the 2013 and 2014 hypertension guidelines.: Position of the Central American and Caribbean Society for Hypertension and Cardiovascular Prevention]. Rev Panam Salud Publica. 2015 Mar;37(3):172-8. Spanish.
Background: PubMed 307047232018 ESC/ESH Guidelines for the management of arterial hypertension. Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):160. doi: 10.1016/j.rec.2018.12.004. No abstract available. English, Spanish.
Background: PubMed 18684369Gonzalez-Juanatey JR, Mazon Ramos P. Cardiovascular prevention (VI). Use of drugs in the primary prevention of arterial hypertension and dyslipidemia. Rev Esp Cardiol. 2008 Aug;61(8):861-79. English, Spanish.
Background: PubMed 20228401ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
Background: PubMed 29899755Guerrero-Garcia C, Rubio-Guerra AF. Combination therapy in the treatment of hypertension. Drugs Context. 2018 Jun 6;7:212531. doi: 10.7573/dic.212531. eCollection 2018.
Background: PubMed 19940300Ernst ME, Moser M. Use of diuretics in patients with hypertension. N Engl J Med. 2009 Nov 26;361(22):2153-64. doi: 10.1056/NEJMra0907219. No abstract available.
Background: PubMed 19713966Kurtz TW, Klein U. Next generation multifunctional angiotensin receptor blockers. Hypertens Res. 2009 Oct;32(10):826-34. doi: 10.1038/hr.2009.135. Epub 2009 Aug 28.
Background: PubMed 32370572Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
Derived from this study: PubMed 40274695Rucker-Joerg IE, Cardona-Munoz EG, Padilla-Padilla FG, Suarez-Otero R, Romero-Antonio Y, Canales-Vazquez E, Rios-Brito KF, Rodriguez-Vazquez IC, Gonzalez-Canudas J. Optimizing Blood Pressure Control: A Randomized Comparative Trial of Losartan/Chlorthalidone vs. Losartan/Hydrochlorothiazide. Cardiol Ther. 2025 Jun;14(2):231-247. doi: 10.1007/s40119-025-00407-7. Epub 2025 Apr 24.
Official Journal of the Federation. PROJECT of Official Mexican Standard PROY-NOM-030-SSA2-2017, For the prevention, detection, diagnosis, treatment and control of systemic arterial hypertension. 2017.Link provided by the sponsor.
Official Mexican NORM NOM-008-SSA3-2017, For the comprehensive treatment of overweight and obesity.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alberto J Zamora Muciño-Arroyo, M.D principal investigator

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)

Francisco Padilla Padilla, M.D principal investigator

Independent

Juan A Peraza Zaldivar, M.D principal investigator

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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?

Change in systolic blood pressure (SBP) (time frame: Baseline and 2 months). The study lists 2 primary outcomes in all. 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 NCT04927299, which also lists 12 linked publications.

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 13 Mar 2025.