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

NCT05144360 | Withdrawn Phase 3 DMC

• 1 other identifier: EMS0220-ATENAS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension Associated; Type II Diabetes Mellitus

Keywords

Hypertension; Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin

  Changes from baseline in glycated hemoglobin

  120 days

• Systolic blood pressure (SBP)

  Changes from baseline in SBP in ambulatory blood pressure monitoring

  120 days

Secondary Outcomes (1)

• Adverse events

  150 days

Study Arms (2)

Atenas association

EXPERIMENTAL

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.

Drug: Atenas

Empagliflozin + telmisartan + amlodipine

ACTIVE COMPARATOR

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.

Drug: Atenas placebo

Interventions

Atenas DRUG

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 association

Atenas placebo DRUG

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

Empagliflozin + telmisartan + amlodipine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: August 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09