Arterial hypertension stage 1.
Conditions
Interventions
It is foreseen the screening of 190 patients. Screen failures at 10% and discontinuation of 25% are expected.
At the initial visit, patients will be evaluated regarding the inclusion and exclusion cri
drug
D03.383.725.203.590
D03.383.725.203.540
Sponsors
Libbs Farmaceutica Ltda
Libbs Farmaceutica Ltda
Eligibility
Age
40 Years to 40 Years
Inclusion criteria
Inclusion criteria: Adult patients over 18 year-old from both genders; ICF signed by the participant; Patients diagnosed with hypertension stage 1, according to the definitions and orientations publicized in the VI Brazilian Arterial Hypertension Guidelines.
Exclusion criteria
Exclusion criteria: fertile women, independently of the use of contraceptive methods; known hypersensitivity to study medications; non-adherence to the placebo treatment during the run-in period; laboratory exams collected in the screening visit considered clinically significant by the investigator; ECG performed during the screening visit showing ventricular arrhythmia, atrium-ventricular block of 2nd or 3rd degree, arrhythmia, tachycardia, bradycardia, or any other alteration considered clinically significant by the investigator; Angina pectoris CCS class III or IV; Decompensate angina pectoris NYHA class II or IV; BMI over 35 kg/m2; moderate or advanced hepatic insufficiency; Severe or decompensate kidney insufficiency, characterized by creatinine clearance lower than 30 mL/min/1,73 m2 of corporal surface or dialyses required; ongoing severe conditions, even if controlled by therapy: gastrointestinal, immunological, cardiovascular or cancer; presence or history of significant edema of lower limbs (++/4+ or more); myocardial infarction, myocardial revascularization or coronary angioplasty in the last 6 months or myocardial revascularization scheduled for the next 6 months; significant or decompensate cardiac valvulopathy; stroke or transient ischemic attack in the last 12 months or carotid revascularization scheduled for the next 6 months; Uncontrolled diabetes (HbA1C over 9%); history of angioneurotic edema; any relevant disease that by investigator judgment may interfere in the study objectives or patients’ risks; psychiatric disease that prevent the patient to participate in the study or cognitive disturbs (demential syndrome of any origin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the two treatment groups with respect to the mean values of SYSTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the two treatment groups with respect to the mean values of DIASTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment. | — |
Countries
Brazil
Contacts
Public ContactDebora Rodrigues
Libbs Farmaceutica Ltda
Outcome results
None listed