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

EMS

Status and phase: Suspended; Phase 3

Conditions: Hypertension

Treatments: Drug: Indapamide / Losartan; Drug: Hyzaar®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620788

LIEMS1111

Details and patient eligibility

About

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.

Full description

• 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

Enrollment: 636 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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636 participants in 4 patient groups

Indapamide 1.5mg / Losartan 50mg

Experimental group

Treatment:

Drug: Indapamide / Losartan

Drug: Indapamide / Losartan

Indapamide 1.5mg / Losartan 100mg

Experimental group

Treatment:

Drug: Indapamide / Losartan

Drug: Indapamide / Losartan

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

Active Comparator group

Treatment:

Drug: Hyzaar®

Drug: Hyzaar®

Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

Active Comparator group

Treatment:

Drug: Hyzaar®

Drug: Hyzaar®