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

February 22, 2021 updated by: EMS

Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LENINGRADO 5

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.
Drug: LENINGRADO 5 association
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • EMS association
Other: Natrilix SR Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo
Active Comparator: 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.
Drug: Natrilix® SR
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Indapamide SR 1,5 mg
Other: Leningrado 5 association Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
Time Frame: 70 days
70 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study
Time Frame: 101 days
101 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0618-LENINGRADO 5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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