Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

July 25, 2022 updated by: EMS

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

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Withdrawn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

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

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.
Drug: LENINGRADO association
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • EMS association
Other: Indapamide SR Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo
Other: Levamlodipine placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo
Active Comparator: 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.
Other: Levamlodipine placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo
Drug: Indapamide SR 1.5 MG
1 coated sustained-release tablet, oral, once a day.
Other: Leningrado association Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo
Active Comparator: 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.
Other: Indapamide SR Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo
Other: Leningrado association Placebo
1 coated sustained-release tablet, oral, once a day.
Other Names:
  • Placebo
Drug: Levamlodipine 2.5/ 5 mg
1 tablet, oral, once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.
Time Frame: 56 days
56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study
Time Frame: 70 days
70 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)

April 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

January 1, 2024

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)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0418 - LENINGRADO

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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