Four oral doses of BI 690517 in patients with Diabetic Nephropathy.
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled (within dose groups) and active controlled (eplerenone group) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 4 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy.
IRAS ID
246112
Contact name
Sue Clark
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2017-000563-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 9 days
Research summary
This study is a randomised, double-blind, placebo-controlled (within dose groups) and active controlled (eplerenone group) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 4 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy. The dose groups are as follows: Dose group 1: 3 mg; Dose group 2: 10 mg; Dose group 3: 20 mg; Dose group 4: 40 mg. The primary endpoint to assess safety and tolerability of BI 690517 is the percentage of patients with drug related Adverse Events (AEs) until end of trial treatment (including the residual effect period). Each dose will be given once per day in the morning for approximately 28 days (4 weeks). Each patient's participation in the trial will last approximately 9 weeks and require approximately 8 visits to the trial clinic. Each patient will undergo physical examinations; have ECGs and various blood tests. The patient will also be required to collect urine samples and complete a medication diary.
REC name
Wales REC 2
REC reference
18/WA/0276
Date of REC Opinion
24 Oct 2018
REC opinion
Further Information Favourable Opinion