Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2024-01-31

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.

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Detailed Description

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Conditions

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Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LENINGRADO

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.

Group Type EXPERIMENTAL

LENINGRADO association

Intervention Type DRUG

1 coated sustained-release tablet, oral, once a day.

Indapamide SR Placebo

Intervention Type OTHER

1 coated sustained-release tablet, oral, once a day.

Levamlodipine placebo

Intervention Type OTHER

1 tablet, oral, once a day.

Indapamide

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.

Group Type ACTIVE_COMPARATOR

Indapamide SR 1.5 MG

Intervention Type DRUG

1 coated sustained-release tablet, oral, once a day.

Leningrado association Placebo

Intervention Type OTHER

1 coated sustained-release tablet, oral, once a day.

Levamlodipine placebo

Intervention Type OTHER

1 tablet, oral, once a day.

Levamlodipine

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.

Group Type ACTIVE_COMPARATOR

Levamlodipine 2.5/ 5 mg

Intervention Type DRUG

1 tablet, oral, once a day.

Leningrado association Placebo

Intervention Type OTHER

1 coated sustained-release tablet, oral, once a day.

Indapamide SR Placebo

Intervention Type OTHER

1 coated sustained-release tablet, oral, once a day.

Interventions

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LENINGRADO association

1 coated sustained-release tablet, oral, once a day.

Intervention Type DRUG

Indapamide SR 1.5 MG

1 coated sustained-release tablet, oral, once a day.

Intervention Type DRUG

Levamlodipine 2.5/ 5 mg

1 tablet, oral, once a day.

Intervention Type DRUG

Leningrado association Placebo

1 coated sustained-release tablet, oral, once a day.

Intervention Type OTHER

Indapamide SR Placebo

1 coated sustained-release tablet, oral, once a day.

Intervention Type OTHER

Levamlodipine placebo

1 tablet, oral, once a day.

Intervention Type OTHER

Other Intervention Names

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EMS association Placebo Placebo Placebo

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No