NCT05144360

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-07-01
• Completion: 2024-11-01
• First posted: 2021-12-03
• Last updated: 2023-09-08