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

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

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.

Study Overview

• Status: Suspended
• Conditions: Hypertension
• Intervention / Treatment: Drug: Indapamide / Losartan; Drug: Indapamide / Losartan; Drug: Hyzaar®

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 636
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide; Indapamide
• Other Study ID Numbers: LIEMS1111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No