Hypertension AssociatedPhase 3ATENASNCT05144360

Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension

A Phase 3 study testing Atenas in people with Hypertension Associated and Type II Diabetes Mellitus, run by EMS.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hypertension Associated, Type II Diabetes Mellitus
What is being tested?: Atenas
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: Aug 2022to Nov 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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Who cannot join

Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
History of alcohol abuse or illicit drug use;
Participation in a clinical trial in the year prior to this study;
Pregnancy or risk of pregnancy and lactating patients;
Known hypersensitivity to any of the formula compounds;
Type 1 diabetes mellitus;
Known or suspected secondary hypertension.

About this study

Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension

The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension

Conditions: Hypertension Associated, Type II Diabetes Mellitus
Being tested: Atenas, Atenas placebo
Keywords: Hypertension, Type II Diabetes Mellitus
Medical subject headings: Diabetes Mellitus, Type 2, Hypertension

What participants receive

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

AtenasDrug
ATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day
Atenas placeboDrug
Drug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day

Study groups in NCT05144360
Study group	Role	What they receive
Atenas association	Experimental	The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Atenas, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan + amlodipine placebo, oral. Receives: Drug: Atenas
Empagliflozin + telmisartan + amlodipine	Active comparator	The patient must take 3 tablets once a day, as follows: 1 tablet Atenas placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan + amlodipine, oral. Receives: Drug: Atenas placebo

What is being measured

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

Glycated hemoglobin
Changes from baseline in glycated hemoglobin
Measured: 120 days
Systolic blood pressure (SBP)
Changes from baseline in SBP in ambulatory blood pressure monitoring
Measured: 120 days

Secondary outcomes (1)

Adverse events
Incidence and severity of adverse events recorded during the study
Measured: 150 days

Timeline

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

Aug 2022Nov 2024

First posted3 Dec 2021
Study startAug 2022 (estimated)
Primary completionJul 2024 (estimated)
Study completionNov 2024 (estimated)

Why it stopped: Strategy review

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypertension AssociatedStudies 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: NCT05144360
Sponsor's protocol ID: EMS0220-ATENAS
Acronym: ATENAS
Status last verified: Sep 2023
First submitted: 22 Nov 2021
Last updated: 8 Sep 2023
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

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All Hypertension Associated trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
ClinicalTrials.gov ID: NCT05144360
Acronym / sponsor ID: ATENAS / EMS0220-ATENAS
Conditions: Hypertension Associated, Type II Diabetes Mellitus
Keywords: Hypertension, Type II Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategy review
Enrolment: 0 participants (actual)
Lead sponsor: EMSIndustry (pharma, biotech, devices)
Study start: Aug 2022 (estimated)
Primary completion: Jul 2024 (estimated)
Study completion: Nov 2024 (estimated)
First posted: 3 Dec 2021 (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 Atenas association in the treatment of type 2 diabetes mellitus and hypertension

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Atenas association	Experimental	Drug: AtenasThe study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Atenas, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan + amlodipine placebo, oral.
Empagliflozin + telmisartan + amlodipine	Active comparator	Drug: Atenas placeboThe patient must take 3 tablets once a day, as follows: 1 tablet Atenas placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan + amlodipine, oral.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Key exclusion criteria (7 listed)

Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
History of alcohol abuse or illicit drug use;
Participation in a clinical trial in the year prior to this study;
Pregnancy or risk of pregnancy and lactating patients;
Known hypersensitivity to any of the formula compounds;

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
AtenasATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day	Drug	Atenas association
Atenas placeboDrug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day	Drug	Empagliflozin + telmisartan + amlodipine

Primary outcome

Glycated hemoglobin
Time frame: 120 days
Changes from baseline in glycated hemoglobin
Systolic blood pressure (SBP)
Time frame: 120 days
Changes from baseline in SBP in ambulatory blood pressure monitoring

1 secondary outcome

Adverse events
Time frame: 150 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 8 Sep 2023.

Related trials for Hypertension Associated

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
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
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Active, not recruitingPhase 2
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RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

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 Atenas in people with Hypertension Associated and Type II Diabetes Mellitus, 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 4 inclusion and 7 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 8 Sep 2023. 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?

Glycated hemoglobin (time frame: 120 days). The study lists 2 primary outcomes in all. 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 NCT05144360.

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 8 Sep 2023.