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

Phase 3

Withdrawn

• Conditions: Arterial Hypertension
• Interventions: Drug: LENINGRADO 5 association; Drug: Natrilix® SR; Other: Natrilix SR Placebo; Other: Leningrado 5 association Placebo

• Registration Number: NCT03814148
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Study Start: 2019-06
• Primary Completion: 2020-06
• Study Completion: 2020-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LENINGRADO 5	LENINGRADO 5 association	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.
LENINGRADO 5	Natrilix SR Placebo	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.
Natrilix® SR	Natrilix® SR	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.
Natrilix® SR	Leningrado 5 association Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.	70 days

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study	101 days