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

Phase 3

Withdrawn

• Conditions: Hypertension Associated; Type II Diabetes Mellitus
• Interventions: Drug: Atenas placebo; Drug: Atenas

• Registration Number: NCT05144360
• Lead Sponsor: EMS

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Study Start: 2022-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-08
• Primary Completion: 2024-07
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin + telmisartan + amlodipine	Atenas placebo	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.
Atenas association	Atenas	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events	150 days	Incidence and severity of adverse events recorded during the study