Arterial HypertensionPhase 3NCT03814109

Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

A Phase 3 study testing LENINGRADO association, Indapamide SR 1.5 MG and Levamlodipine 2.5/ 5 mg in people with Arterial Hypertension, run by EMS.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Arterial Hypertension
What is being tested?: LENINGRADO association, Indapamide SR 1.5 MG and Levamlodipine 2.5/ 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Apr 2022to Jan 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 13Show fewer

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.

About this study

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

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

Conditions: Arterial Hypertension
Being tested: LENINGRADO association, Indapamide SR 1.5 MG, Levamlodipine 2.5/ 5 mg, Leningrado association Placebo, Indapamide SR Placebo
Keywords: Hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LENINGRADO associationDrug
Also called EMS association
1 coated sustained-release tablet, oral, once a day.
Indapamide SR 1.5 MGDrug
1 coated sustained-release tablet, oral, once a day.
Levamlodipine 2.5/ 5 mgDrug
1 tablet, oral, once a day.
Leningrado association PlaceboOther
Also called Placebo
1 coated sustained-release tablet, oral, once a day.
Indapamide SR PlaceboOther
Also called Placebo
1 coated sustained-release tablet, oral, once a day.
Levamlodipine placeboOther
Also called Placebo
1 tablet, oral, once a day.

Study groups in NCT03814109
Study group	Role	What they receive
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. Receives: Drug: LENINGRADO association; Other: Indapamide SR Placebo; Other: 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. Receives: Drug: Indapamide SR 1.5 MG; Other: Leningrado association Placebo; Other: 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. Receives: Drug: Levamlodipine 2.5/ 5 mg; Other: Leningrado association Placebo; Other: Indapamide SR Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.
Measured: 56 days

Secondary outcomes (1)

Incidence and severity of adverse events recorded during the study
Measured: 70 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2022Jan 2024

First posted23 Jan 2019
Study startApr 2022 (estimated)
Primary completionNov 2023 (estimated)
Study completionJan 2024 (estimated)

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arterial HypertensionStudies of the same condition, open and under way.
More trials run by EMSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03814109
Sponsor's protocol ID: EMS0418 - LENINGRADO
Status last verified: Jul 2022
First submitted: 22 Jan 2019
Last updated: 27 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03814109
Acronym / sponsor ID: EMS0418 - LENINGRADO
Conditions: Arterial Hypertension
Keywords: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Sponsor decision
Enrolment: 0 participants (actual)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: Apr 2022 (estimated)
Primary completion: Nov 2023 (estimated)
Study completion: Jan 2024 (estimated)
First posted: 23 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
LENINGRADO	Experimental	Drug: LENINGRADO association, Other: Indapamide SR Placebo, Other: Levamlodipine placeboThe 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.
Indapamide	Active comparator	Drug: Indapamide SR 1.5 MG, Other: Leningrado association Placebo, Other: Levamlodipine placeboThe 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.
Levamlodipine	Active comparator	Drug: Levamlodipine 2.5/ 5 mg, Other: Leningrado association Placebo, Other: Indapamide SR PlaceboThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LENINGRADO associationAlso: EMS association1 coated sustained-release tablet, oral, once a day.	Drug	LENINGRADO
Indapamide SR 1.5 MG1 coated sustained-release tablet, oral, once a day.	Drug	Indapamide
Levamlodipine 2.5/ 5 mg1 tablet, oral, once a day.	Drug	Levamlodipine
Leningrado association PlaceboAlso: Placebo1 coated sustained-release tablet, oral, once a day.	Other	Indapamide, Levamlodipine
Indapamide SR PlaceboAlso: Placebo1 coated sustained-release tablet, oral, once a day.	Other	LENINGRADO, Levamlodipine
Levamlodipine placeboAlso: Placebo1 tablet, oral, once a day.	Other	Indapamide, LENINGRADO

Primary outcome

Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.
Time frame: 56 days

1 secondary outcome

Incidence and severity of adverse events recorded during the study
Time frame: 70 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.

Related trials for Arterial Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LENINGRADO association, Indapamide SR 1.5 MG and Levamlodipine 2.5/ 5 mg in people with Arterial Hypertension, run by EMS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit. (time frame: 56 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.