NCT04927299

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Essential Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Losartan/Chlorthalidone in fixed dose	1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
DRUG	Losartan + hydrochlorothiazide in fixed dose	1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-08-15
• Completion: 2023-09-11
• First posted: 2021-06-15
• Last updated: 2025-03-13

Locations

1 site across 1 country: Mexico