Status:
RECRUITING
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. ...
Eligibility Criteria
Inclusion
- At least 18 years old at time of consent
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
- Participants with medical history of hypertension and on active pharmacological treatment
- Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
- Established cardiovascular (CV) disease and on active pharmacological treatment
- At least one additional risk factor for developing heart failure (HF)
Exclusion
- History of HF or hospitalization for HF or treatment of HF
- Atrial fibrillation or Atrial flutter with a resting heart rate \>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
- Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
- Treatment with an Mineralocorticoid receptor antagonist (MRA)
- Treatment with amiloride or other potassium-sparing diuretic
- Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:
- A direct renin inhibitor (e.g. aliskiren)
- More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
- Other aldosterone synthase inhibitors (e.g. baxdrostat)
- Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2029
Estimated Enrollment :
11800 Patients enrolled
Trial Details
Trial ID
NCT07064473
Start Date
May 9 2025
End Date
December 21 2029
Last Update
March 4 2026
Active Locations (1154)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Eastern Shore Research Group
Fairhope, Alabama, United States, 36532
3
Lakeview Clinical Research
Guntersville, Alabama, United States, 35976
4
Arizona Clinical Trials - Chandler
Chandler, Arizona, United States, 85225