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

NCT04927299 | Completed Phase 3

• 1 other identifier: SIL-30601-III-20(1)
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Arterial Hypertension

Keywords

Hypertension; Blood pressure; Diuretic; Losartan; Chlorthalidone

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 2 months

Secondary Outcomes (4)

• Dosage adjustment requirement

  2 months

• Subjects who achieved blood pressure reduction goals

  2 months

• Percentage of adherence to treatment

  2 months

• Adverse events

  2 months

Study Arms (2)

Group A: Losartan + chlorthalidone

EXPERIMENTAL

Administered orally, one tablet a day, for 2 months.

Drug: Losartan/Chlorthalidone in fixed dose

Group B: Losartan + hydrochlorothiazide

ACTIVE COMPARATOR

Administered orally, one tablet a day, for 2 months.

Drug: Losartan + hydrochlorothiazide in fixed dose

Interventions

Losartan/Chlorthalidone in fixed dose DRUG

1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg

Also known as: LOS/CHLORTHA

Group A: Losartan + chlorthalidone

Losartan + hydrochlorothiazide in fixed dose DRUG

1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg

Also known as: LOS/HYDROCHLO

Group B: Losartan + hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.).

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (12)

• 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.

  PMID: 29133356 BACKGROUND

• 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.

  PMID: 15652604 BACKGROUND

• 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.

  PMID: 12748199 BACKGROUND

• 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.

  PMID: 25988254 BACKGROUND

• 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.

  PMID: 30704723 BACKGROUND

• 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.

  PMID: 18684369 BACKGROUND

• 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.

  PMID: 20228401 BACKGROUND

• 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.

  PMID: 29899755 BACKGROUND

• 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.

  PMID: 19940300 BACKGROUND

• 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.

  PMID: 19713966 BACKGROUND

• 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.

  PMID: 32370572 BACKGROUND

• 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.

  PMID: 40274695 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Chlorthalidone; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Benzenesulfonamides; Sulfonamides; Amides; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorothiazide; Benzothiadiazines; Thiazides

Study Officials

• Alberto J Zamora Muciño-Arroyo, M.D

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

  PRINCIPAL INVESTIGATOR

• Francisco Padilla Padilla, M.D

  Independent

  PRINCIPAL INVESTIGATOR

• Juan A Peraza Zaldivar, M.D

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

  PRINCIPAL INVESTIGATOR

• Luis M Román Pintos, PhD

  Hospital Hispano S.A. de C.V.

  PRINCIPAL INVESTIGATOR

• Ernesto G Cardona Muñoz, M.D

  Independent

  PRINCIPAL INVESTIGATOR

• Cinthia L Patiño Bernal, M.D

  CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 15, 2021
• Study Start: June 30, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 11, 2023
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)