Hypertension
Conditions
Brief summary
The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.
Detailed description
* open label,randomized, multicenter * Experiment duration: 12 weeks. * 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization). * evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension * Adverse events evaluation
Interventions
DRUGIndapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
DRUGHyzaar®
1 tablet of Hyzaar®, oral, a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults male or female aged ≥ 18 years old; * Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements, * Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant, * Patient who accept the discontinuation of previous hypertension therapy.
Exclusion criteria
* Patients with blood pressure ≥ 180/100 mmHg; * Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics; * Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine\> 1.5 mg / dL); * Patients with hypo or hyperkalemia (serum potassium outside normal range); * Patients with ALT greater than 2.5 the upper limit of normal or active liver disease; * Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period; * Patients on drug or alcohol abuse in the last two years; * Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome); * Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation; * Refusal or inability to provide the Informed Consent Term.; * Refusal to discontinue the anti-hypertensive medication. * Patients at the discretion of the investigator does not have indication for discontinuing the current medications;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in systemic blood pressure measurements after 12 weeks | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety Will be Evaluated by the Adverse Events Occurrences | 12 weeks |
Countries
Brazil
Outcome results
None listed