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

Study Overview
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Brief Summary
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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.

Detailed Description
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open label,randomized, multicenter Experiment duration: 12 weeks. 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization). evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension Adverse events evaluation

Official Title
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Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Indapamide / Losartan
* Drug: Indapamide / Losartan
* Drug: Hyzaar®
* Drug: Hyzaar®


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indapamide 1.5mg / Losartan 50mg<br> | Drug: Indapamide / Losartan<br>* 1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day<br>* Other names: Indapamide 1.5mg / Losartan 50mg;|
| Experimental: Indapamide 1.5mg / Losartan 100mg<br> | Drug: Indapamide / Losartan<br>* 1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day<br>* Other names: Indapamide 1.5mg / Losartan 100mg;|
| Active Comparator: Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)<br> | Drug: Hyzaar®<br>* 1 tablet of Hyzaar®, oral, a day<br>* Other names: Losartan 50mg/Hydrochlorothiazide12,5mg;|
| Active Comparator: Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)<br> | Drug: Hyzaar®<br>* 1 tablet of Hyzaar®, oral, a day<br>* Other names: Losartan 100mg/Hydrochlorothiazide 25mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systemic blood pressure measurements after 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Will be Evaluated by the Adverse Events Occurrences |  | 12 weeks |