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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014