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Completed

NCT Number: NCT01857622

Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

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Key information

Conditions

Non-valvular Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo Women's Medical University Hospital

Tokyo, 162-0054, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

Exclusion criteria

  • Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
  • Patients who are at a significantly high risk for bleeding
  • Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
  • Patients who have evidence of hepatic function test abnormalities

Treatment and study plan

DU-176b 15mg

Drug

oral DU-176b 15mg once daily

Other names: edoxaban

DU-176b 30mg

Drug

oral DU-176b 30mg once daily

Other names: edoxaban

DU-176b 60mg

Drug

oral DU-176b 60mg once daily

Other names: edoxaban

Primary outcomes

  1. Incidence of Any Adjudicated Bleeding Events

    Time frame: 3 months

    Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 20, 2013
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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