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A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the 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

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the 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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Oct 2019

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At a glance

  • Drugs Finerenone (Primary)
  • Indications Diabetic nephropathies; Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms ARTS-DN Japan
  • Sponsors Bayer
  • Most Recent Events

    • 04 Oct 2019 Population pharmacokinetics and pharmacodynamics (PD) analysis for efficacy and safety markers based on data from two clinical phase IIb studies ARTS-DN (NCT01874431) and ARTS DN Japan (NCT01968668); results published in the Clinical Pharmacokinetics
    • 01 Apr 2018 Primary endpoint (Change of urinary albumin-to creatinine ratio) has been met, according to results published in the Journal of Diabetes and its Complications.
    • 01 Dec 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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