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NCT07064473 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Hypertension and Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 11,800
- Enrollment target
- 20
- Study locations
NCT07064473 is a Phase 3 study of Hypertension and Diabetes Mellitus, Type 2 that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 11,800 participants, above the 3,482-participant average among 470 other Hypertension trials with a reported enrollment target (239% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT07064473, a Phase 3 study of Hypertension and Diabetes Mellitus, Type 2, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 11,800 participants
- Enrollment target
- 20
- Study locations
Study 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. 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.
Conditions Studied
Interventions
- DRUG Empagliflozin
- DRUG Vicadrostat
- DRUG Placebo matching Vicadrostat
Study Locations (20)
California
- National Heart Institute - Beverly Hills - Beverly Hills
- Hope Clinical Research - Canoga Park
- John Muir Physician Network Clinical Research Center - Concord
- Velocity Clinical Research-Huntington Park - Huntington Park
- Velocity Clinical Research, San Diego - La Mesa
- First Valley Medical Group - Lancaster
- ARK Clinical Research - Long Beach
- Diabetes Associates Medical Group - Orange
- Empire Clinical Research - Pomona
- Velocity Clinical Research - San Bernardino - San Bernardino
- Acclaim Clinical Research - San Diego
Arizona
- Arizona Clinical Trials - Chandler - Chandler
- Elite Clinical Studies - Phoenix
- Clinical Research Institute of Arizona, LLC - Sun City West
- Fiel Family & Sports Medicine - Tempe
- Arizona Clinical Trials - Tucson
- Yuma Clinical Trials - Yuma
Alabama
- Pinnacle Research Group, LLC - Anniston
- Eastern Shore Research Group - Fairhope
- Lakeview Clinical Research - Guntersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,800 participants |
| Start Date | 2025-05-09 |
| Est. Completion | 2029-12-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07064473
The ClinicalTrials.gov registry entry for NCT07064473 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 11,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,482-participant average among 470 other Hypertension trials with a reported enrollment target (239% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Empagliflozin is the first listed.
NCT07064473 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT07064473 about?
NCT07064473 is a clinical study titled "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". 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 empaglifl...
What is the current status of trial NCT07064473?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 11,800 participants. The study started on 2025-05-09. Estimated completion is 2029-12-21.
What conditions does trial NCT07064473 study?
This clinical trial studies the following conditions: Hypertension, Diabetes Mellitus, Type 2, Cardiovascular Diseases.
What interventions are being tested in trial NCT07064473?
The interventions under investigation include: Empagliflozin (DRUG), Vicadrostat (DRUG), Placebo matching Vicadrostat (DRUG).
Who is sponsoring clinical trial NCT07064473?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07064473 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.