Overview
Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control
Status:
Withdrawn
Withdrawn
Trial end date:
2017-08-01
2017-08-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
EMSTreatments:
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 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;