Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control

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

Study Overview

• Status: Withdrawn
• Conditions: Essential Arterial Hypertension
• Intervention / Treatment: Drug: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg; Drug: Olmesartan medoxomil 20mg + Chlortalidone 25mg; Drug: Olmesartan 20mg + hydrochlorothiazide 12,5mg

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion Criteria:

• Patients with any clinically significant disease that in the investigator is 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 in urine sample greater than 30 mg/g;
• Patients with history of hypersensitivity to any of the formula compounds;
• Pregnancy or risk of pregnancy and lactating patients;
• Participation in clinical trial in the year prior to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1: Olmesartan + Chlorthalidone; The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning.	Drug: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg; 1 tablet a day
Experimental: Test 2: Olmesartan + Chlorthalidone; The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning.	Drug: Olmesartan medoxomil 20mg + Chlortalidone 25mg; 1 tablet a day
Experimental: Comparator: Benicar HCT®; The patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.	Drug: Olmesartan 20mg + hydrochlorothiazide 12,5mg; 1 tablet a day; Other Names: Benicar HCT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety will be evaluated by the occurrences of adverse events.	9 weeks

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start: December 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion: November 1, 2026

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimated): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Amides; Benzene Derivatives; Phthalimides; Isoindoles; Benzenesulfonamides; Sulfonamides; Sulfones; Ketones; Tetrazoles; Benzophenones; Imides; Olmesartan Medoxomil; Chlorthalidone; olmesartan
• Other Study ID Numbers: OLCEMS0514OR-III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No