Trials / Completed
CompletedNCT03165240
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
Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor \[ACEi\] or Angiotensin-receptor blockers \[ARB\]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio \[UACR\].
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 690517 | Film-coated tablet |
| DRUG | Eplerenone | Film-coated tablet |
| DRUG | Placebo | Film-coated tablet |
Timeline
- Start date
- 2017-10-05
- Primary completion
- 2020-04-16
- Completion
- 2020-05-07
- First posted
- 2017-05-24
- Last updated
- 2024-09-20
Locations
40 sites across 10 countries: Denmark, France, Germany, Greece, Portugal, Russia, Slovakia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT03165240. Inclusion in this directory is not an endorsement.