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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Essential Arterial Hypertension

Intervention / Treatment
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* Drug: Losartan/Chlorthalidone in fixed dose
* Drug: Losartan + hydrochlorothiazide in fixed dose


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Diuretic, Losartan, Chlorthalidone, Hypertension