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

Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in 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: Not yet recruiting
• Conditions: Arterial Hypertension
• Intervention / Treatment: Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg; Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg; Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg; Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Monalisa F.B. Oliveira, M.D.; Phone Number: 55; Email: pesquisa.clinica@ems.com.br

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 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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1: Olmesartan+Chlorthalidone; The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.	Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg; 1 tablet a day
Experimental: Test 2: Olmesartan+Chlorthalidone; The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.	Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg; 1 tablet a day
Active Comparator: Comparator 1: Benicar HCT®; The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.	Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg; 1 tablet a day; Other Names: Benicar HCT
Active Comparator: Comparator 2: Benicar HCT®; The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.	Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg; 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	Measure Description	Time Frame
Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	9 weeks

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimated): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

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; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide; Chlorthalidone
• Other Study ID Numbers: OLCEMS0215

Drug and device information, study documents

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