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

Type II Diabetes Mellitus Clinical Trial

— ATENAS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05144360
• Other study ID #: EMS0220-ATENAS
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2022
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type II Diabetes Mellitus

Intervention

Drug:
• Atenas
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
• Atenas 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	Changes from baseline in glycated hemoglobin	120 days
Primary	Systolic blood pressure (SBP)	Changes from baseline in SBP in ambulatory blood pressure monitoring	120 days
Secondary	Adverse events	Incidence and severity of adverse events recorded during the study	150 days