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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Chlorthalidone; Hydrochlorothiazide; Losartan

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.).