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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Type II Diabetes Mellitus; Hypertension Associated

Treatments: Drug: Atenas; Drug: Atenas placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05144360

EMS0220-ATENAS

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Atenas association

Experimental group

Description:

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.

Treatment:

Drug: Atenas

Empagliflozin + telmisartan + amlodipine

Active Comparator group

Description:

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.

Treatment:

Drug: Atenas placebo