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

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ClinicalTrials.gov Identifier: NCT01857622
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-valvular Atrial Fibrillation Drug: DU-176b 15mg Drug: DU-176b 30mg Drug: DU-176b 60mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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)
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SRI 15mg
DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
Drug: DU-176b 15mg
oral DU-176b 15mg once daily
Other Name: edoxaban
Experimental: Normal/MiRI low-dose group
DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
Drug: DU-176b 30mg
oral DU-176b 30mg once daily
Other Name: edoxaban
Experimental: Normal/MiRI high-dose group
DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
Drug: DU-176b 60mg
oral DU-176b 60mg once daily
Other Name: edoxaban



Primary Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857622


Locations
Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan, 162-0054
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Yukihiro Koretsune, Dir Osaka National Hospital

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01857622     History of Changes
Other Study ID Numbers: DU176b-B-J307
First Posted: May 20, 2013    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
anticoagulant
DU-176b
edoxaban
factor Xa
oral
atrial fibrillation
severe renal impairment

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants