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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05144360

Acronym

ATENAS

Enrollment

Registered

2021-12-03

Start date

2022-08-31

Completion date

2024-11-30

Last updated

2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Associated, Type II Diabetes Mellitus

Keywords

Hypertension, Type II Diabetes Mellitus

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

Interventions

DRUGAtenas

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

DRUGAtenas 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse events	150 days	Incidence and severity of adverse events recorded during the study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026