Clinical trial NCT04927299: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Arterial Hypertension
Keywords: Hypertension
Blood pressure
Diuretic
Losartan
Chlorthalidone
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Change in systolic blood pressure (SBP)
timeFrame: Baseline and 2 months
measure: Change in diastolic blood pressure (DBP)
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Dosage adjustment requirement
timeFrame: 2 months
measure: Subjects who achieved blood pressure reduction goals
timeFrame: 2 months
measure: Percentage of adherence to treatment
timeFrame: 2 months
measure: Adverse events
timeFrame: 2 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
name: Alberto J Zamora Muciño-Arroyo, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Francisco Padilla Padilla, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
name: Juan A Peraza Zaldivar, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Hispano S.A. de C.V.
name: Luis M Román Pintos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Ernesto G Cardona Muñoz, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.
name: Cinthia L Patiño Bernal, M.D
role: PRINCIPAL_INVESTIGATOR
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