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NCT03165227 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
75
Enrollment target

NCT03165227 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 75 participants.

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The verdict

NCT03165227, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG BI 685509

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2017-10-17
Est. Completion 2019-12-10
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT03165227

The ClinicalTrials.gov registry entry for NCT03165227 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03165227 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03165227 about?

NCT03165227 is a clinical study titled "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)". 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 objectiv...

What is the current status of trial NCT03165227?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2017-10-17. Estimated completion is 2019-12-10.

What interventions are being tested in trial NCT03165227?

The interventions under investigation include: Placebo (DRUG), BI 685509 (DRUG).

Who is sponsoring clinical trial NCT03165227?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.