Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

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

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

Conditions
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Arterial Hypertension

Intervention / Treatment
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* Drug: LENINGRADO association
* Drug: Indapamide SR 1.5 MG
* Drug: Levamlodipine 2.5/ 5 mg
* Other: Leningrado association Placebo
* Other: Indapamide SR Placebo
* Other: Levamlodipine placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged 18 years or more; Participants diagnosed with hypertension (mild to moderate), mild to moderate cardiovascular risk, 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 taget organ damage; 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LENINGRADO<br>The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day. | Drug: LENINGRADO association<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: EMS association;Other: Indapamide SR Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;Other: Levamlodipine placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;|
| Active Comparator: Indapamide<br>The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day. | Drug: Indapamide SR 1.5 MG<br>* 1 coated sustained-release tablet, oral, once a day.<br>Other: Leningrado association Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;Other: Levamlodipine placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;|
| Active Comparator: Levamlodipine<br>The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day. | Drug: Levamlodipine 2.5/ 5 mg<br>* 1 tablet, oral, once a day.<br>Other: Leningrado association Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;Other: Indapamide SR Placebo<br>* 1 coated sustained-release tablet, oral, once a day.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit. |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study |  | 70 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension