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

May 16, 2013
May 16, 2013
November 2011
January 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
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)
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Non-valvular Atrial Fibrillation
  • Drug: DU-176b 15mg
    oral DU-176b 15mg once daily
    Other Name: edoxaban
  • Drug: DU-176b 30mg
    oral DU-176b 30mg once daily
    Other Name: edoxaban
  • Drug: DU-176b 60mg
    oral DU-176b 60mg once daily
    Other Name: edoxaban
  • Experimental: SRI 15mg
    DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
    Intervention: Drug: DU-176b 15mg
  • 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.
    Intervention: Drug: DU-176b 30mg
  • 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.
    Intervention: Drug: DU-176b 60mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01857622
DU176b-B-J307
Yes
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
Daiichi Sankyo Co., Ltd.
Not Provided
Principal Investigator: Yukihiro Koretsune, Dir Osaka National Hospital
Daiichi Sankyo Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP