Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Vicadrostat for Diabetes Mellitus, Type 2

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.

Official registry: https://clinicaltrials.gov/study/NCT07064473 · Boehringer Ingelheim · enrollment listed as 11,800

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vicadrostat, Empagliflozin, or Placebo matching Vicadrostat. The registry lists allocation as randomized. This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease.

They plan to enroll about 11,800 people at 1137 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease

Interventions: Vicadrostat, Empagliflozin, Placebo matching Vicadrostat

Primary outcome (registry wording): Time to first event of cardiovascular (CV) death or heart failure event (HFE)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • At least 18 years old at time of consent
  • 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)

Public study contact (from the registry)

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1137 listed

+ 930 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07064473 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07064473?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07064473?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary