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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Arterial Hypertension

Treatments: Drug: Natrilix® SR; Drug: LENINGRADO 5 association; Other: Natrilix SR Placebo; Other: Leningrado 5 association Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03814148

EMS0618-LENINGRADO 5

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

LENINGRADO 5

Experimental group

Description:

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.

Treatment:

Other: Natrilix SR Placebo

Drug: LENINGRADO 5 association

Natrilix® SR

Active Comparator group

Description:

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.

Treatment:

Other: Leningrado 5 association Placebo

Drug: Natrilix® SR