Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-03-12 @ 5:02 AM
Study NCT ID:
NCT03128320
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Randomized, Single-blind, Threefold Crossover, Single-center Study to Assess the Safety and the Effects of 1 mg and 5 mg BAY1193397 in Comparison to Placebo on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure After Single Dose in Type II Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003799-63 | EUDRACT_NUMBER | None | View |