Overview

Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
EMS
Treatments:
Indapamide
Niacin
Criteria
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.