Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-07 @ 12:44 AM
Study NCT ID:
NCT02345057
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria
Status:
COMPLETED
Status Verified Date:
2016-09
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:
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.
The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).
The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: