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

Primary Purpose

Essential Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Losartan/Chlorthalidone in fixed dose
Losartan + hydrochlorothiazide in fixed dose
Sponsored by
Laboratorios Silanes S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Arterial Hypertension focused on measuring Hypertension, Blood pressure, Diuretic, Losartan, Chlorthalidone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Losartan + chlorthalidone

Group B: Losartan + hydrochlorothiazide

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Dosage adjustment requirement
Describe the proportion of subjects who required dose adjustment per treatment group.
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.
Percentage of adherence to treatment
Assess the percentage of adherence to treatment during the intervention, by pill count.
Adverse events
Describe the frequency and intensity of adverse events and adverse reactions presented during the study by treatment group.

Full Information

First Posted
June 8, 2021
Last Updated
April 3, 2023
Sponsor
Laboratorios Silanes S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04927299
Brief Title
Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Silanes S.A. de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Arterial Hypertension
Keywords
Hypertension, Blood pressure, Diuretic, Losartan, Chlorthalidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Losartan + chlorthalidone
Arm Type
Experimental
Arm Description
Administered orally, one tablet a day, for 2 months.
Arm Title
Group B: Losartan + hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
Administered orally, one tablet a day, for 2 months.
Intervention Type
Drug
Intervention Name(s)
Losartan/Chlorthalidone in fixed dose
Other Intervention Name(s)
LOS/CHLORTHA
Intervention Description
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Intervention Type
Drug
Intervention Name(s)
Losartan + hydrochlorothiazide in fixed dose
Other Intervention Name(s)
LOS/HYDROCHLO
Intervention Description
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Primary Outcome Measure Information:
Title
Change in systolic blood pressure (SBP)
Description
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.
Time Frame
Baseline and 2 months
Title
Change in diastolic blood pressure (DBP)
Description
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.
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Dosage adjustment requirement
Description
Describe the proportion of subjects who required dose adjustment per treatment group.
Time Frame
2 months
Title
Subjects who achieved blood pressure reduction goals
Description
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.
Time Frame
2 months
Title
Percentage of adherence to treatment
Description
Assess the percentage of adherence to treatment during the intervention, by pill count.
Time Frame
2 months
Title
Adverse events
Description
Describe the frequency and intensity of adverse events and adverse reactions presented during the study by treatment group.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge A González, PhD
Phone
5254883785
Ext
3761
Email
jogonzalez@silanes.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Yulia Romero-Antonio, B.S.
Phone
5554883700
Ext
3777
Email
yromero@silanes.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto J Zamora Muciño-Arroyo, M.D
Organizational Affiliation
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Padilla Padilla, M.D
Organizational Affiliation
Independent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan A Peraza Zaldivar, M.D
Organizational Affiliation
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis M Román Pintos, PhD
Organizational Affiliation
Hospital Hispano S.A. de C.V.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernesto G Cardona Muñoz, M.D
Organizational Affiliation
Independent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cinthia L Patiño Bernal, M.D
Organizational Affiliation
CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratorio Silanes, S.A. de C.V.
City
Mexico City
ZIP/Postal Code
11000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge A Gonzalez, PhD
Phone
+5254883785
Ext
3761
Email
jogonzalez@silanes.com.mx
First Name & Middle Initial & Last Name & Degree
Yulia Romero-Antonio, B.S.
Phone
5554883700
Ext
3777
Email
yromero@silanes.com.mx
First Name & Middle Initial & Last Name & Degree
Alberto J Zamora Muciño-Arroyo, M.D.
First Name & Middle Initial & Last Name & Degree
Francisco G Padilla Padilla, M.D.
First Name & Middle Initial & Last Name & Degree
Juan A Peraza Zaldivar, M.D.
First Name & Middle Initial & Last Name & Degree
Luis M Román Pintos, PhD
First Name & Middle Initial & Last Name & Degree
Ernesto G Cardona Muñoz, M.D.
First Name & Middle Initial & Last Name & Degree
Cinthia L Patiño Bernal, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.dof.gob.mx/nota_detalle.php?codigo=5480159&fecha=19/04/2017
Description
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.
URL
http://www.dof.gob.mx/nota_detalle.php?codigo=5523105&fecha=18/05/2018
Description
Official Mexican NORM NOM-008-SSA3-2017, For the comprehensive treatment of overweight and obesity.

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

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