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

• Status: Withdrawn
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Indapamide

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.