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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
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.
Time frame: 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.
Time frame: Baseline and 2 months
Dosage adjustment requirement
Describe the proportion of subjects who required dose adjustment per treatment group.
Time frame: 2 months
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.
Time frame: 2 months
Percentage of adherence to treatment
Assess the percentage of adherence to treatment during the intervention, by pill count.
Time frame: 2 months
Adverse events
Describe the frequency and intensity of adverse events and adverse reactions presented during the study by treatment group.
Time frame: 2 months
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