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

Sponsor

EMS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05144360

Collaborator

(none)

496

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Associated Type II Diabetes Mellitus	Drug: Atenas Drug: Atenas placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

496 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atenas association 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.	Drug: Atenas 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
Active Comparator: Empagliflozin + telmisartan + amlodipine 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.	Drug: Atenas placebo 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

Arm

Intervention/Treatment

Experimental: Atenas association

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.

Drug: Atenas

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

Active Comparator: Empagliflozin + telmisartan + amlodipine

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.

Drug: Atenas placebo

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events [150 days]
Incidence and severity of adverse events recorded during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EMS

ClinicalTrials.gov Identifier:

NCT05144360

Other Study ID Numbers:

EMS0220-ATENAS

First Posted:

Dec 3, 2021

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by EMS

Hypertension

Type II Diabetes Mellitus

Additional relevant MeSH terms:

Hypertension

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 6, 2022