Clinical trial NCT01620788: Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment
Official title: Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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;

Primary outcomes:
measure: Changes in systemic blood pressure measurements after 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety Will be Evaluated by the Adverse Events Occurrences
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References: