Actively Recruiting
EASi-PROTKT14 - A Phase III Double-blind, Randomised Trial Comparing Vicadrostat and Empagliflozin to Placebo and Empagliflozin in Adults With Type 2 Diabetes, Hypertension, and Cardiovascular Disease
Led by Boehringer Ingelheim · Updated on 2026-05-29
11800
Participants Needed
1152
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.
CONDITIONS
Brief Title
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at time of consent
- Signed and dated written informed consent according to regulations before joining the trial
- Women of childbearing potential must be able and willing to use highly effective birth control methods
- Medical history of hypertension and currently receiving treatment
- Medical history of type 2 diabetes mellitus and currently receiving treatment
- Established cardiovascular disease and currently receiving treatment
- At least one additional risk factor for developing heart failure
You will not qualify if you...
- History of heart failure or hospitalization for heart failure or treatment of heart failure
- Atrial fibrillation or atrial flutter with resting heart rate over 110 bpm documented at screening
- Advanced untreated conduction disease or relevant ventricular arrhythmia at screening
- Treatment with mineralocorticoid receptor antagonists
- Treatment with amiloride or other potassium-sparing diuretics
- Use of direct renin inhibitors or more than one ACE inhibitor or angiotensin receptor blocker simultaneously
- Use of other aldosterone synthase inhibitors or systemic mineralocorticoid replacement therapy
- Further exclusion criteria apply
Research Team
B
Boehringer Ingelheim
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