Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan Cilexetil + Chlorthalidone (16mg + 12.5mg and 16mg + 25mg) Compared With HYZAAR® in Hypertension Control

EMS0 sitesNovember 2016

ConditionsEssential Arterial Hypertension

InterventionsCandesartan + Chlorthalidone Losartan+hydrochlorothiazide

Overview

Phase: Phase 3
Intervention: Candesartan + Chlorthalidone
Conditions: Essential Arterial Hypertension
Sponsor: EMS
Primary Endpoint: Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Status: Withdrawn
Last Updated: 9 years 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

November 2016

End Date

August 2017

Last Updated

9 years 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 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;