Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension (ATENAS)

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Amlodipine; Empagliflozin; Telmisartan; Telmisartan amlodipine combination

Criteria

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.