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

Primary Purpose

Hypertension

Status

Suspended

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Indapamide / Losartan

Hyzaar®

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Allergisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Indapamide 1.5mg / Losartan 50mg

Indapamide 1.5mg / Losartan 100mg

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

Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

Arm Description

Outcomes

Primary Outcome Measures

Changes in systemic blood pressure measurements after 12 weeks

Secondary Outcome Measures

Safety Will be Evaluated by the Adverse Events Occurrences

Full Information

NCT ID

NCT01620788

First Posted

May 29, 2012

Last Updated

July 25, 2022

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01620788

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Suspended

Why Stopped

Substancial amendment

Study Start Date

November 27, 2019 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

636 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Indapamide 1.5mg / Losartan 50mg

Arm Type

Experimental

Arm Title

Indapamide 1.5mg / Losartan 100mg

Arm Type

Experimental

Arm Title

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

Arm Type

Active Comparator

Arm Title

Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Indapamide / Losartan

Other Intervention Name(s)

Indapamide 1.5mg / Losartan 50mg

Intervention Description

1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day

Intervention Type

Drug

Intervention Name(s)

Indapamide / Losartan

Other Intervention Name(s)

Indapamide 1.5mg / Losartan 100mg

Intervention Description

1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day

Intervention Type

Drug

Intervention Name(s)

Hyzaar®

Other Intervention Name(s)

Losartan 50mg/Hydrochlorothiazide12,5mg

Intervention Description

1 tablet of Hyzaar®, oral, a day

Intervention Type

Drug

Intervention Name(s)

Hyzaar®

Other Intervention Name(s)

Losartan 100mg/Hydrochlorothiazide 25mg

Intervention Description

1 tablet of Hyzaar®, oral, a day

Primary Outcome Measure Information:

Title

Changes in systemic blood pressure measurements after 12 weeks

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Safety Will be Evaluated by the Adverse Events Occurrences

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Facility Information:

Facility Name

Allergisa

City

Campinas

State/Province

São Paulo

Country

Brazil

12. IPD Sharing Statement

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

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