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

EMS0 sites261 target enrollmentJuly 9, 2015

ConditionsEssential Arterial Hypertension

InterventionsOlmesartan Medoxomil 20mg + Chlorthalidone 12,5mg Olmesartan medoxomil 20mg + Chlortalidone 25mg Olmesartan 20mg + hydrochlorothiazide 12,5mg

DrugsOlmesartan Medoxomil 20mg + Chlorthalidone 12,5mg Olmesartan medoxomil 20mg + Chlortalidone 25mg Olmesartan 20mg + hydrochlorothiazide 12,5mg

Overview

Phase: Phase 3
Intervention: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg
Conditions: Essential Arterial Hypertension
Sponsor: EMS
Enrollment: 261
Primary Endpoint: Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
Status: Withdrawn
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 9, 2015

End Date

June 1, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EMS

Responsible Party

Sponsor

Eligibility Criteria

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;