Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control

NCT ID: NCT02483936

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.

Detailed Description

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Conditions

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Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test 1: Olmesartan+Chlorthalidone

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Group Type EXPERIMENTAL

Olmesartan medoxomil 40mg + chlorthalidone 12,5mg

Intervention Type DRUG

1 tablet a day

Test 2: Olmesartan+Chlorthalidone

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.

Group Type EXPERIMENTAL

Olmesartan medoxomil 40mg + chlorthalidone 25mg

Intervention Type DRUG

1 tablet a day

Comparator 1: Benicar HCT®

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

Group Type ACTIVE_COMPARATOR

Olmesartan 40mg + Hydrochlorothiazide 12,5mg

Intervention Type DRUG

1 tablet a day

Comparator 2: Benicar HCT®

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Group Type ACTIVE_COMPARATOR

Olmesartan 40mg + Hydrochlorothiazide 25mg

Intervention Type DRUG

1 tablet a day

Interventions

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Olmesartan medoxomil 40mg + chlorthalidone 12,5mg

1 tablet a day

Intervention Type DRUG

Olmesartan medoxomil 40mg + chlorthalidone 25mg

1 tablet a day

Intervention Type DRUG

Olmesartan 40mg + Hydrochlorothiazide 12,5mg

1 tablet a day

Intervention Type DRUG

Olmesartan 40mg + Hydrochlorothiazide 25mg

1 tablet a day

Intervention Type DRUG

Other Intervention Names

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Benicar HCT Benicar HCT

Eligibility Criteria

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Inclusion Criteria

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.

Exclusion Criteria

* Patients with any clinically significant disease that in the investigator opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL / min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactation patients;
* Participation in clinical trial in the year prior to this study;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OLCEMS0215

Identifier Type: -

Identifier Source: org_study_id

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