Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Phase 3
Not yet recruiting
- Conditions
- Essential Arterial Hypertension
- Interventions
- Registration Number
- NCT02493322
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 261
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test 1: Olmesartan + Chlorthalidone Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning. Test 2: Olmesartan + Chlorthalidone Olmesartan medoxomil 20mg + Chlortalidone 25mg The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning. Comparator: Benicar HCT® Olmesartan 20mg + hydrochlorothiazide 12,5mg The patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
- Primary Outcome Measures
Name Time Method Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. 60 days
- Secondary Outcome Measures
Name Time Method Safety will be evaluated by the occurrences of adverse events. 9 weeks