Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control
Overview
- Phase
- Phase 3
- Intervention
- Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
- Conditions
- Arterial Hypertension
- Sponsor
- EMS
- Enrollment
- 348
- Primary Endpoint
- Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
- Status
- Withdrawn
- Last Updated
- 4 months ago
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.
Investigators
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;
Arms & Interventions
Test 1: Olmesartan+Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.
Intervention: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
Test 2: Olmesartan+Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.
Intervention: Olmesartan medoxomil 40mg + chlorthalidone 25mg
Comparator 1: Benicar HCT®
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
Intervention: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
Comparator 2: Benicar HCT®
The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.
Intervention: Olmesartan 40mg + Hydrochlorothiazide 25mg
Outcomes
Primary Outcomes
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
Time Frame: 60 days
Secondary Outcomes
- Safety will be evaluated by the adverse events occurrences(9 weeks)