NCT03814109

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
3.2 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

January 22, 2019

Last Update Submit

July 25, 2022

Conditions

Arterial Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.

    56 days

Secondary Outcomes (1)

  • Incidence and severity of adverse events recorded during the study

    70 days

Study Arms (3)

LENINGRADO

EXPERIMENTAL

The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day.

Drug: LENINGRADO associationOther: Indapamide SR PlaceboOther: Levamlodipine placebo

Indapamide

ACTIVE COMPARATOR

The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day.

Drug: Indapamide SR 1.5 MGOther: Leningrado association PlaceboOther: Levamlodipine placebo

Levamlodipine

ACTIVE COMPARATOR

The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day.

Drug: Levamlodipine 2.5/ 5 mgOther: Leningrado association PlaceboOther: Indapamide SR Placebo

Interventions

LENINGRADO associationDRUG

1 coated sustained-release tablet, oral, once a day.

Also known as: EMS association
LENINGRADO
Indapamide SR 1.5 MGDRUG

1 coated sustained-release tablet, oral, once a day.

Indapamide
Levamlodipine 2.5/ 5 mgDRUG

1 tablet, oral, once a day.

Levamlodipine
Leningrado association PlaceboOTHER

1 coated sustained-release tablet, oral, once a day.

Also known as: Placebo
IndapamideLevamlodipine
Indapamide SR PlaceboOTHER

1 coated sustained-release tablet, oral, once a day.

Also known as: Placebo
LENINGRADOLevamlodipine
Levamlodipine placeboOTHER

1 tablet, oral, once a day.

Also known as: Placebo
IndapamideLENINGRADO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 23, 2019

Study Start

April 1, 2022

Primary Completion

November 1, 2023

Study Completion

January 1, 2024

Last Updated

July 27, 2022

Record last verified: 2022-07