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Hypertension | Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment

Hypertension research study

What is the primary objective of this study?

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

Who is eligible to participate?

Inclusion Criteria: - Adults male or female aged ≥ 18 years old; - Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements, - Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant, - Patient who accept the discontinuation of previous hypertension therapy. Exclusion Criteria: - Patients with blood pressure ≥ 180/100 mmHg; - Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics; - Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL); - Patients with hypo or hyperkalemia (serum potassium outside normal range); - Patients with ALT greater than 2.5 the upper limit of normal or active liver disease; - Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period; - Patients on drug or alcohol abuse in the last two years; - Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome); - Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation; - Refusal or inability to provide the Informed Consent Term.; - Refusal to discontinue the anti-hypertensive medication. - Patients at the discretion of the investigator does not have indication for discontinuing the current medications;

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Indapamide / Losartan1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day

Drug:Indapamide / Losartan1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day

Drug:Hyzaar®1 tablet of Hyzaar®, oral, a day

Drug:Hyzaar®1 tablet of Hyzaar®, oral, a day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Indapamide 1.5mg / Losartan 50mg

Indapamide 1.5mg / Losartan 100mg

Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)

Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

Study Status

Not yet recruiting

Start Date: September 2018

Completed Date: March 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Changes in systemic blood pressure measurements after 12 weeks

Secondary Outcome: Safety Will be Evaluated by the Adverse Events Occurrences

Study sponsors, principal investigator, and references

Principal Investigator: Otávio Berwanger, MD

Lead Sponsor: EMS

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01620788

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