Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Arterial Hypertension

Treatments: Other: Levamlodipine placebo; Drug: LENINGRADO association; Drug: Indapamide SR 1.5 MG; Drug: Levamlodipine 2.5/ 5 mg; Other: Indapamide SR Placebo; Other: Leningrado association Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03814109

EMS0418 - LENINGRADO

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Leningrado 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 (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

LENINGRADO

Experimental group

Description:

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.

Treatment:

Other: Indapamide SR Placebo

Drug: LENINGRADO association

Other: Levamlodipine placebo

Indapamide

Active Comparator group

Description:

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.

Treatment:

Drug: Indapamide SR 1.5 MG

Other: Leningrado association Placebo

Other: Levamlodipine placebo

Levamlodipine

Active Comparator group

Description:

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.

Treatment:

Other: Indapamide SR Placebo

Other: Leningrado association Placebo

Drug: Levamlodipine 2.5/ 5 mg