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

• Status: Withdrawn
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Candesartan; Candesartan cilexetil; Chlorthalidone; Hydrochlorothiazide; Losartan

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;

• Pregnancy or risk of pregnancy and lactating patients;

• Participation in clinical trial in the year prior to this study.