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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01857622
First received: May 16, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention Phase
Non-valvular Atrial Fibrillation
Drug: DU-176b 15mg
Drug: DU-176b 30mg
Drug: DU-176b 60mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Incidence of any adjudicated bleeding events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)

  • Incidence of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Incidence of adverse events

  • Incidence of adverse drug reactions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Incidence of adverse drug reactions

  • Plasma concentration of DU-176b [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Plasma concentration of DU-176b

  • Plasma concentration of D21-2393 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Plasma concentration of D21-2393


Secondary Outcome Measures:
  • Incidence of adjudicated thromboembolic events (cerebral infarction and systemic embolism) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Incidence of adjudicated thromboembolic events (cerebral infarction and systemic embolism)


Enrollment: 93
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01857622     History of Changes
Other Study ID Numbers: DU176b-B-J307
Study First Received: May 16, 2013
Last Updated: May 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
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

ClinicalTrials.gov processed this record on April 17, 2014