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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814148
Recruitment Status : Withdrawn (The design of this protocol was rewritten due to regulatory recommendations.)
First Posted : January 23, 2019
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
EMS

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Drug: LENINGRADO 5 association Drug: Natrilix® SR Other: Natrilix SR Placebo Other: Leningrado 5 association Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Indapamide

Arms and Interventions
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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 Name: EMS association

Other: Natrilix SR Placebo
1 coated sustained-release tablet, oral, once a day.
Other Name: 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 Name: Indapamide SR 1,5 mg

Other: Leningrado 5 association Placebo
1 coated sustained-release tablet, oral, once a day.
Other Name: Placebo


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

Secondary Outcome Measures :
  1. Incidence and severity of adverse events recorded during the study [ Time Frame: 101 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03814148    
Other Study ID Numbers: EMS0618-LENINGRADO 5
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Indapamide
Antihypertensive Agents
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action