Trials / Completed
CompletedNCT03165227
This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)
Randomised, Double-blind, Placebo-controlled Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Multiple Rising Oral Doses of BI 685509 Over 28 Days in Male and Female Patients With Diabetic Nephropathy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 685509 | Taken orally |
| DRUG | Placebo | Taken orally |
Timeline
- Start date
- 2017-10-17
- Primary completion
- 2019-12-10
- Completion
- 2019-12-10
- First posted
- 2017-05-24
- Last updated
- 2020-01-13
Locations
35 sites across 5 countries: United States, Belgium, Canada, Czechia, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03165227. Inclusion in this directory is not an endorsement.