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

Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03814148
• Other study ID #: EMS0618-LENINGRADO 5
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2019
• Est. completion date: September 2020

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Drug:
• LENINGRADO 5 association
1 coated sustained-release tablet, oral, once a day.
• Natrilix® SR
1 coated sustained-release tablet, oral, once a day.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.		70 days
Secondary	Incidence and severity of adverse events recorded during the study		101 days