Overview

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.