Vicadrostat and Empagliflozin for Type 2 Diabetes

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 Phase 3 Interventional Study
Diabetes Mellitus, Type 2 Hypertension Cardiovascular Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
11,800 (estimated)
Sponsor
Boehringer Ingelheim · Industry
Who this trial is looking for

This trial is looking for adults with type 2 diabetes, high blood pressure, and heart disease. Participants will take either the study medication or a placebo daily for up to 4 years.

Are You a Good Fit for This Trial?
Must not be taking Direct renin inhibitorsMore than one ACE inhibitor or ARBOther aldosterone synthase inhibitorsSystemic mineralocorticoid replacement therapy

You may be able to join if

  • I am at least 18 years old.
  • I have high blood pressure and I am on medication for it.
  • I have been diagnosed with type 2 diabetes.
  • I am on medication for type 2 diabetes.
  • I have heart disease and I am on medication for it.
  • I have at least one additional risk factor for heart failure.

You may not be able to join if

  • I have a history of heart failure.
  • I have atrial fibrillation or flutter with a high resting heart rate.
  • I have advanced untreated heart conduction problems.
  • I am taking a mineralocorticoid receptor antagonist.
  • I am taking amiloride or other potassium-sparing diuretics.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 cont…
Contacts

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

CONTACT