Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Arterial Hypertension Clinical Trial

Official title:

Randomized, Double-blind, Triple-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03814109
• Other study ID #: EMS0418 - LENINGRADO
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 2022
• Est. completion date: January 2024

Study information

• Verified date: July 2022
• 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 association on the treatment of hypertension.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: November 2023
• 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 (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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Drug:
• LENINGRADO association
1 coated sustained-release tablet, oral, once a day.
• Indapamide SR 1.5 MG
1 coated sustained-release tablet, oral, once a day.
• Levamlodipine 2.5/ 5 mg
1 tablet, oral, once a day.

Other:
• Leningrado association Placebo
1 coated sustained-release tablet, oral, once a day.
• Indapamide SR Placebo
1 coated sustained-release tablet, oral, once a day.
• Levamlodipine placebo
1 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 24h-ABPM at the initial visit and final visit.		56 days
Secondary	Incidence and severity of adverse events recorded during the study		70 days