Tests vicadrostat with empagliflozin in adults with type 2 diabetes and heart disease
Tests vicadrostat taken with empagliflozin in adults with diabetes, high blood pressure and heart disease.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Aichi, Kariya, Aichi, Kasugai, Aichi, Nagoya, Chiba, Chiba, Chiba, Ichikawa, Chiba, Matsudo, Chiba, Narashino, Ehime, Matsuyama, Fukuoka, Chikushino, Fukuoka, Fukuoka, Gumma, Maebashi, Gumma, Takasaki, Hiroshima, Hiroshima, Hiroshima, Kure, Hokkaido, Asahikawa, Hokkaido, Sapporo, Hyogo, Nishinomiya, Ibaraki, Higashiibaraki-gun, Ibaraki, Mito, Ibaraki, Naka, Ibaraki, Tsukuba, Ishikawa, Kanazawa, Iwate, Morioka, Kagawa, Kanonji, Kagawa, Takamatsu, Kagoshima, Kagoshima, Kanagawa, Miura-gun, Kanagawa, Sagamihara, Kanagawa, Yokohama, Kochi, Kochi, Kumamoto, Kumamoto, Kumamoto, Kyoto, Kyoto, Miyagi, Sendai, Miyazaki, Miyakonojo, Nagano, Matsumoto, Nagasaki, Nagasaki, Okayama, Okayama, Osaka, Daito, Osaka, Matsubara, Osaka, Moriguchi, Osaka, Osaka, Osaka, Suita, Saitama, Ageo, Saitama, Koshigaya, Saitama, Saitama, Saitama, Tokorozawa, Shizuoka, Fujieda, Shizuoka, Sunto-gun, Tochigi, Shimotsuga-gun, Tochigi, Shimotsuke, Tokushima, Tokushima, Tokyo, Hachioji, Tokyo, Itabashi-ku, Tokyo, Minato-ku, Tokyo, Ota-ku, Toyama, Toyama, and Toyoake-shi, JapanSee the 80 sites
- Phase
- Phase 3
Where in Japan
- Kariya Toyota General HospitalAichi, Kariya, JapanTaking people
- Kasugai Municipal HospitalAichi, Kasugai, JapanTaking people
- Japan Community Healthcare Organization Chukyo HospitalAichi, Nagoya, JapanTaking people
- Nagoya University HospitalAichi, Nagoya, JapanTaking people
- Chiba University HospitalChiba, Chiba, JapanTaking people
- Japan Institute for Health Security National Kohnodai Medical CenterChiba, Ichikawa, JapanTaking people
- Chibanishi General HospitalChiba, Matsudo, JapanTaking people
- Chibaken Saiseikai Narashino HospitalChiba, Narashino, JapanTaking people
- Ehime Prefectural Central HospitalEhime, Matsuyama, JapanTaking people
- Saiseikai Matsuyama HospitalEhime, Matsuyama, JapanTaking people
- Fukuokaken Saiseikai Futsukaichi HospitalFukuoka, Chikushino, JapanTaking people
- Fukuoka University HospitalFukuoka, Fukuoka, JapanTaking people
- Japanese Red Cross Fukuoka HospitalFukuoka, Fukuoka, JapanTaking people
- Gunma Saiseikai Maebashi HospitalGumma, Maebashi, JapanTaking people
- Japanese Red Cross Maebashi HospitalGumma, Maebashi, JapanTaking people
- National Hospital Organization Takasaki General Medical CenterGumma, Takasaki, JapanTaking people
- Hiroshima Red Cross Hospital and Atomic-bomb Survivors HospitalHiroshima, Hiroshima, JapanTaking people
- Kure Kyosai HospitalHiroshima, Kure, JapanTaking people
- National Hospital Organization Kure Medical Center and Chugoku Cancer CenterHiroshima, Kure, JapanTaking people
- Asahikawa Medical University HospitalHokkaido, Asahikawa, JapanTaking people
- Hanaoka Seishu Memorial HospitalHokkaido, Sapporo, JapanTaking people
- Manda Memorial Hospital Diabetes CenterHokkaido, Sapporo, JapanTaking people
- Teine Keijinkai HospitalHokkaido, Sapporo, JapanTaking people
- Hyogo Prefectural Nishinomiya General Medical CenterHyogo, Nishinomiya, JapanTaking people
- Nishinomiya Watanabe Cardiovascular Cerebral CenterHyogo, Nishinomiya, JapanTaking people
- NHO Mito Medical CenterIbaraki, Higashiibaraki-gun, JapanTaking people
- Iryouhouijneiwakai Minamiakatsuka ClinicIbaraki, Mito, JapanTaking people
- Naka Memorial ClinicIbaraki, Naka, JapanTaking people
- Tsukuba Medical Center HospitalIbaraki, Tsukuba, JapanTaking people
- Kanazawa University HospitalIshikawa, Kanazawa, JapanTaking people
- National Hospital Organization Kanazawa Medical CenterIshikawa, Kanazawa, JapanTaking people
- Iwate Prefectural Central HospitalIwate, Morioka, JapanTaking people
- Mitoyo General HospitalKagawa, Kanonji, JapanTaking people
- Kagawa Prefectural Central HospitalKagawa, Takamatsu, JapanTaking people
- Yokoi Medical ClinicKagawa, Takamatsu, JapanTaking people
- Nanpuh HospitalKagoshima, Kagoshima, JapanTaking people
- Tenyoukai Central ClinicKagoshima, Kagoshima, JapanTaking people
- Tokushukai Hayama Heart CenterKanagawa, Miura-gun, JapanTaking people
- Kitasato University HospitalKanagawa, Sagamihara, JapanTaking people
- Yokohama City University HospitalKanagawa, Yokohama, JapanTaking people
- Yokohama Minami Kyousai HospitalKanagawa, Yokohama, JapanTaking people
- Yokohama Rosai HospitalKanagawa, Yokohama, JapanTaking people
- Chikamori HospitalKochi, Kochi, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Saiseikai Kumamoto HospitalKumamoto, Kumamoto, JapanTaking people
- Kyoto Medical CenterKyoto, Kyoto, JapanTaking people
- Kyoto University HospitalKyoto, Kyoto, JapanTaking people
- Rakuwakai Otowa HospitalKyoto, Kyoto, JapanTaking people
- Sendai Cardiovascular CenterMiyagi, Sendai, JapanTaking people
- Shinden Higashi ClinicMiyagi, Sendai, JapanTaking people
- Tohoku Kosai HospitalMiyagi, Sendai, JapanTaking people
- Medicalcity East HospitalMiyazaki, Miyakonojo, JapanTaking people
- Shinshu University HospitalNagano, Matsumoto, JapanTaking people
- Nagasaki Harbor Medical CenterNagasaki, Nagasaki, JapanTaking people
- Juzenkai The Sakakibara Heart Institute of OkayamaOkayama, Okayama, JapanTaking people
- Okayama City General Medical Center Okayama City HospitalOkayama, Okayama, JapanTaking people
- Okayama Rosai HospitalOkayama, Okayama, JapanTaking people
- Nozaki Tokushukai HospitalOsaka, Daito, JapanTaking people
- Matsubara Tokushukai HospitalOsaka, Matsubara, JapanTaking people
- Matsushita Memorial HospitalOsaka, Moriguchi, JapanTaking people
- Chibune General HospitalOsaka, Osaka, JapanTaking people
- Ikebuchi ClinicOsaka, Osaka, JapanTaking people
- National Cerebral and Cardiovascular CenterOsaka, Suita, JapanTaking people
- Saiseikai Senri HospitalOsaka, Suita, JapanTaking people
- Ageo Central General HospitalSaitama, Ageo, JapanTaking people
- Koshigaya Municipal HospitalSaitama, Koshigaya, JapanTaking people
- San-Ai HospitalSaitama, Saitama, JapanTaking people
- Saino ClinicSaitama, Tokorozawa, JapanTaking people
- Fujieda Municipal General HospitalShizuoka, Fujieda, JapanTaking people
- Shizuoka Medical CenterShizuoka, Sunto-gun, JapanTaking people
- Dokkyo Medical University HospitalTochigi, Shimotsuga-gun, JapanTaking people
- Jichi Medical University HospitalTochigi, Shimotsuke, JapanTaking people
- Tokushima University HospitalTokushima, Tokushima, JapanTaking people
- Minamino Cardiovascular HospitalTokyo, Hachioji, JapanTaking people
- Nihon University Itabashi HospitalTokyo, Itabashi-ku, JapanTaking people
- Tokyo Saiseikai Central HospitalTokyo, Minato-ku, JapanTaking people
- Toranomon HospitalTokyo, Minato-ku, JapanTaking people
- Tokyo Rosai HospitalTokyo, Ota-ku, JapanTaking people
- Toyama Prefectural Central HospitalToyama, Toyama, JapanTaking people
- Fujita Health University HospitalToyoake-shi, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07064473EU 2025-521188-11-00
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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: Treatment with an Mineralocorticoid receptor antagonist (MRA); 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; 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 amiloride or other potassium-sparing diuretic.