Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.

Official Title
-----------------
Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension

Conditions
-----------------
Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: LENINGRADO 5 association
* Drug: Natrilix® SR
* Other: Natrilix SR Placebo
* Other: Leningrado 5 association Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged 18 years or more; Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification; Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; BP ≥ 180/110 mmHg; Participants with BMI (body mass index) ≥ 40 Kg/m2; Previous diagnosis of secondary hypertension; History of Target Organ Injury; History of cardiovascular, hepatic and renal disease; History of gout, Diabetes Mellitus and hypokalemia; Current medical history of cancer; Current smoking; History of alcohol abuse or drug use; Pregnancy or risk of pregnancy and lactating patients; Known allergy or hypersensitivity to the medicines components used during the clinical trial; Participation in clinical trial in the year prior to this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LENINGRADO 5<br>The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo. | Drug: LENINGRADO 5 association<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: EMS association;Other: Natrilix SR Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;|
| Active Comparator: Natrilix® SR<br>The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo. | Drug: Natrilix® SR<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Indapamide SR 1,5 mg;Other: Leningrado 5 association Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit. |  | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study |  | 101 days |