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

Last updated: February 22, 2021
Sponsor: EMS
Overall Status: Trial Not Available

Phase

3

Condition

High Blood Pressure (Hypertension - Pediatric)

High Blood Pressure (Hypertension)

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT03814148
EMS0618-LENINGRADO 5
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants aged 18 years or more;
  • Participants diagnosed with hypertension, not controlled by monotherapy and/ orlifestyle modification;

Exclusion

Exclusion Criteria:

  • Any clinical and laboratory findings that, in the judgment of the investigator, mayinterfere 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 clinicaltrial;
  • Participation in clinical trial in the year prior to this study.

Study Design

Study Start date:
June 01, 2019
Estimated Completion Date:
September 30, 2020