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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-07-16

No results posted yet for this study

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)

Conditions

  • Diabetic Nephropathies

Interventions

DRUG

BAY94-8862

1.25 mg BAY94-8862 tablet once daily in the morning

DRUG

BAY94-8862

2.5 mg BAY94-8862 tablet once daily in the morning

DRUG

BAY94-8862

5 mg BAY94-8862 tablet once daily in the morning

DRUG

BAY94-8862

7.5 mg BAY94-8862 tablet once daily in the morning

DRUG

BAY94-8862

10 mg BAY94-8862 tablet once daily in the morning

DRUG

Placebo

Placebo tablet once daily in the morning

DRUG

BAY 94-8862

15 mg BAY 94-8862 tablet once daily in the morning

DRUG

BAY 94-8862

20 mg BAY 94-8862 tablet once daily in the morning

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968668 on ClinicalTrials.gov