Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

NCT01968668 ↗

Phase 2 Completed 96 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)

Timeline

Start: 2013-10-28
Primary completion: 2014-10-09
Completion: 2014-11-07

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Finerenone	Small molecule	1.25 mg	Oral
Subject	Finerenone	Small molecule	2.5 mg	Oral
Subject	Finerenone	Small molecule	5 mg	Oral
Subject	Finerenone	Small molecule	7.5 mg	Oral
Subject	Finerenone	Small molecule	10 mg	Oral
Subject	Finerenone	Small molecule	15 mg	Oral
Subject	Finerenone	Small molecule	20 mg	Oral

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

Summary

Timeline

Publications

Drugs

Indications