Status:

WITHDRAWN

Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Lead Sponsor:

EMS

Conditions:

Arterial Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03814109

Start Date

April 1 2022

End Date

January 1 2024

Last Update

July 27 2022

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