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
Recruiting · NCT07064473 · Interventional (participants receive a specific treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
60 locations listed across 39 US states.
- Pinnacle Research Group, LLC - Anniston, Alabama, United States
- Eastern Shore Research Group - Fairhope, Alabama, United States
- Lakeview Clinical Research - Guntersville, Alabama, United States
- Arizona Clinical Trials - Chandler - Chandler, Arizona, United States
- Elite Clinical Studies - Phoenix, Arizona, United States
- Clinical Research Institute of Arizona, LLC - Sun City West, Arizona, United States
- Fiel Family & Sports Medicine - Tempe, Arizona, United States
- Arizona Clinical Trials - Tucson, Arizona, United States
- Yuma Clinical Trials - Yuma, Arizona, United States
- National Heart Institute - Beverly Hills, California, United States
- Hope Clinical Research - Canoga Park, California, United States
- John Muir Physician Network Clinical Research Center - Concord, California, United States
- Velocity Clinical Research-Huntington Park - Huntington Park, California, United States
- Velocity Clinical Research, San Diego - La Mesa, California, United States
- First Valley Medical Group - Lancaster, California, United States
- ARK Clinical Research - Long Beach, California, United States
- Diabetes Associates Medical Group - Orange, California, United States
- Empire Clinical Research - Pomona, California, United States
- Velocity Clinical Research - San Bernardino - San Bernardino, California, United States
- Acclaim Clinical Research - San Diego, California, United States
- NorthBay Clinical Research, LLC - Santa Rosa, California, United States
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance, California, United States
- Blue Coast Research Center, LLC - Vista, California, United States
- Rocky Mountain Regional VA Medical Center - Aurora, Colorado, United States
- OptumCare Clinical Trials, LLC - Golden, Colorado, United States
- Cardiology Physicians of Fairfield County - Bridgeport - Bridgeport, Connecticut, United States
- CMR of Greater New Haven, LLC - Hamden, Connecticut, United States
- Cardiology Associates of Fairfield County - Stamford, Connecticut, United States
- Excel Medical Clinical Trials - Boca Raton, Florida, United States
- Clinical Research of West Florida, Inc. - Clearwater, Florida, United States
- Beautiful Minds Clinical Research Center - Cutler Bay, Florida, United States
- Hillcrest Medical Research - DeLand, Florida, United States
- University Clinical Research Deland, LLC - DeLand, Florida, United States
- Universal Axon Clinical Research - Doral, Florida, United States
- Northeast Research Institute - Fleming Island, Florida, United States
- Covenant Metabolic Specialists, LLC - Fort Myers - Fort Myers, Florida, United States
- Velocity Clinical Research-Hallandale Beach-67888 - Hallandale, Florida, United States
- Northeast Research Institute - Jacksonville, Florida, United States
- Westside Center for Clinical Research - Jacksonville, Florida, United States
- East Coast Institute for Research, LLC - Southside - Jacksonville, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- Walgreens - Kissimmee - Site 4442 - Kissimmee, Florida, United States
- East Coast Institute for Research - Lake City - Lake City, Florida, United States
- Clinical Research of Central Florida - Lakeland - Lakeland, Florida, United States
- Finlay Medical Research Corp - Miami, Florida, United States
- Optimus U Corporation-Miami-69452 - Miami, Florida, United States
- Oceane7 Clinical Research - Miami, Florida, United States
- Research Institute of South Florida, Inc. - Miami, Florida, United States
- IMIC Inc. - Miami, Florida, United States
- Alma Clinical Research, Inc. - Miami, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- Advanced Research for Health Improvement, LLC - Naples, Florida, United States
- Suncoast Clinical Research - New Port Richey, Florida, United States
- Florida Institute for Clinical Research - Orlando, Florida, United States
- Ormond Beach Clinical Research - Ormond Beach, Florida, United States
- Cardiology Partners Clinical Research Institute - Palm Beach Gardens, Florida, United States
- Innovation Medical Research Center - Palmetto Bay, Florida, United States
- Center for Diabetes, Obesity and Metabolism - Pembroke Pines, Florida, United States
- Peace River Cardiovascular Center - Port Charlotte, Florida, United States
- Covenant Metabolic Specialists, LLC - Brandon - Riverview, Florida, United States
Showing 60 of 1147 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →