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

Phase 3

Not yet recruiting

• Conditions: Arterial Hypertension
• Interventions: Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg; Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg; Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg; Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg

• Registration Number: NCT02483936
• Lead Sponsor: EMS

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Start: 2024-12
• Primary Completion: 2025-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 348

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 2: Olmesartan+Chlorthalidone	Olmesartan medoxomil 40mg + chlorthalidone 25mg	The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
Comparator 1: Benicar HCT®	Olmesartan 40mg + Hydrochlorothiazide 12,5mg	The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Test 1: Olmesartan+Chlorthalidone	Olmesartan medoxomil 40mg + chlorthalidone 12,5mg	The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Comparator 2: Benicar HCT®	Olmesartan 40mg + Hydrochlorothiazide 25mg	The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Primary Outcome Measures

Name	Time	Method
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.	60 days

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	9 weeks	Adverse events will be collected and followed in order to evaluate safety and tolerability