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

April 3, 2024 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto J Zamora Muciño-Arroyo, M.D.
        • Principal Investigator:
          • Francisco G Padilla Padilla, M.D.
        • Principal Investigator:
          • Luis M Román Pintos, PhD
        • Principal Investigator:
          • Juan A Peraza Zaldivar, M.D.
        • Principal Investigator:
          • Ernesto G Cardona Muñoz, M.D.
        • Principal Investigator:
          • Cinthia L Patiño Bernal, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Losartan + chlorthalidone
Administered orally, one tablet a day, for 2 months.
Drug: Losartan/Chlorthalidone in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Other Names:
  • LOS/CHLORTHA
Active Comparator: Group B: Losartan + hydrochlorothiazide
Administered orally, one tablet a day, for 2 months.
Drug: Losartan + hydrochlorothiazide in fixed dose
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Other Names:
  • LOS/HYDROCHLO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 months
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.
Baseline and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosage adjustment requirement
Time Frame: 2 months
Describe the proportion of subjects who required dose adjustment per treatment group.
2 months
Subjects who achieved blood pressure reduction goals
Time Frame: 2 months
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.
2 months
Percentage of adherence to treatment
Time Frame: 2 months
Assess the percentage of adherence to treatment during the intervention, by pill count.
2 months
Adverse events
Time Frame: 2 months
Describe the frequency and intensity of adverse events and adverse reactions presented during the study by treatment group.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Alberto J Zamora Muciño-Arroyo, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
  • Principal Investigator: Juan A Peraza Zaldivar, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
  • Principal Investigator: Ernesto G Cardona Muñoz, M.D, Independent
  • Principal Investigator: Francisco Padilla Padilla, M.D, Independent
  • Principal Investigator: Luis M Román Pintos, PhD, Hospital Hispano S.A. de C.V.
  • Principal Investigator: Cinthia L Patiño Bernal, M.D, CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30601-III-20(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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