Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control

Phase 3

Withdrawn

• Conditions: Essential Arterial Hypertension
• Interventions: Drug: Losartan+hydrochlorothiazide; Drug: Candesartan + Chlorthalidone

• Registration Number: NCT02521246
• Lead Sponsor: EMS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Study Start: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator: Losartan+hydrochlorothiazide (Hyzaar®)	Losartan+hydrochlorothiazide	The patients will take 1 tablet (Losartan 100 mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Test 1: Candesartan + Chlorthalidone	Candesartan + Chlorthalidone	The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Test 2: Candesartan + Chlorthalidone	Candesartan + Chlorthalidone	The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 25 mg) a day, in the morning.

Primary Outcome Measures

Name	Time	Method
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal	60 days

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences.	9 weeks