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BI 690517

DRUG15 trials

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Universitair Medisch Centrum Groningen, Boehringer Ingelheim

Conditions

Chronic kidney diseaseDiabetic NephropathiesHealthyHeart failureHeart failure (HF)Kidney Disease, ChronicLiver DiseasesType 2 diabetes

Phase 1

Single Rising Dose Study of BI 690517 in Healthy Volunteers
CompletedNCT02891148
Boehringer IngelheimHealthy
Start: 2016-09-29End: 2016-12-12Updated: 2024-09-20
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
CompletedNCT03100916
Boehringer IngelheimHealthy
Start: 2017-05-05End: 2017-11-24Updated: 2024-09-20
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
CompletedNCT03165240
Boehringer IngelheimDiabetic Nephropathies
Start: 2017-10-05End: 2020-05-07Updated: 2024-09-20
This Study is Done in Healthy Chinese and Japanese Volunteers; it Looks at How BI 690517 is Taken up in the Body and How Well it is Tolerated
CompletedNCT03206632
Boehringer IngelheimHealthy
Start: 2017-07-17End: 2017-10-13Updated: 2024-09-20
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are Tolerated
CompletedNCT03608072
Boehringer IngelheimHealthy
Start: 2018-08-06End: 2019-01-31Updated: 2024-11-25
A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body
CompletedNCT05515588
Boehringer IngelheimHealthy
Start: 2022-09-19End: 2022-11-17Updated: 2024-09-20
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
CompletedNCT05731908
Boehringer IngelheimHealthy, Liver Diseases
Start: 2023-02-21End: 2023-04-13Updated: 2024-09-20

Phase 2

Phase 3

EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease
RecruitingCTIS2024-511025-63-00
Boehringer Ingelheim International GmbHChronic kidney disease
Start: 2024-10-21Target: 2500Updated: 2026-01-14
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
RecruitingNCT06531824
Boehringer IngelheimKidney Disease, Chronic
Start: 2024-08-13End: 2028-08-30Target: 11000Updated: 2026-04-02
EASi-HF Preserved – 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 symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) ≥40%
RecruitingCTIS2023-509706-30-00
Boehringer Ingelheim International GmbHHeart failure (HF)
Start: 2024-10-18Target: 2461Updated: 2026-01-12
EASi-HF Reduced – 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 symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%
RecruitingCTIS2024-519525-38-00
Boehringer Ingelheim International GmbHHeart failure
Start: 2025-08-22Target: 1539Updated: 2026-01-12
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
RecruitingCTIS2025-521188-11-00
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.cardiovascular disease, hypertension, Type 2 diabetes
Start: 2025-10-15Target: 4576Updated: 2026-01-27

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