Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial Hypertension
NCT ID: NCT04927299
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
163 participants
INTERVENTIONAL
2022-06-30
2023-09-11
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Losartan + chlorthalidone
Administered orally, one tablet a day, for 2 months.
Losartan/Chlorthalidone in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Group B: Losartan + hydrochlorothiazide
Administered orally, one tablet a day, for 2 months.
Losartan + hydrochlorothiazide in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Interventions
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Losartan/Chlorthalidone in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Losartan + hydrochlorothiazide in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* 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.).
18 Years
65 Years
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Alberto J Zamora Muciño-Arroyo, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
Francisco Padilla Padilla, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Juan A Peraza Zaldivar, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
Luis M Román Pintos, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Hispano S.A. de C.V.
Ernesto G Cardona Muñoz, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Cinthia L Patiño Bernal, M.D
Role: PRINCIPAL_INVESTIGATOR
CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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.
Official Mexican NORM NOM-008-SSA3-2017, For the comprehensive treatment of overweight and obesity.
Other Identifiers
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SIL-30601-III-20(1)
Identifier Type: -
Identifier Source: org_study_id
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