Arterial Hypertension
Conditions
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.
Interventions
DRUGOlmesartan medoxomil 40mg + chlorthalidone 12,5mg
1 tablet a day
DRUGOlmesartan medoxomil 40mg + chlorthalidone 25mg
1 tablet a day
DRUGOlmesartan 40mg + Hydrochlorothiazide 12,5mg
1 tablet a day
DRUGOlmesartan 40mg + Hydrochlorothiazide 25mg
1 tablet a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. | 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | 9 weeks | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Outcome results
None listed