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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Arterial Hypertension

Intervention: Olmesartan Medoxomil + Chlorthalidone (Drug); Olmesartan medoxomil + Chlortalidone (Drug); Losartan + hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: EMS

Overall contact:
Joyce M. Silva, M.D., Phone: +551938879851, Email: pesquisa.clinica@ems.com.br


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal

Secondary outcome: Safety will be evaluated by the occurrences of adverse events.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Joyce M. Silva, M.D., Phone: +551938879851, Email: pesquisa.clinica@ems.com.br

Additional Information

Starting date: January 2016
Last updated: July 8, 2015

Page last updated: August 23, 2015

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