Back to results

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

Primary Purpose

Non-valvular Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

DU-176b 15mg

DU-176b 30mg

DU-176b 60mg

About this trial

This is an interventional prevention trial for Non-valvular Atrial Fibrillation focused on measuring anticoagulant, DU-176b, edoxaban, factor Xa, oral, atrial fibrillation, severe renal impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tokyo Women's Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

SRI 15mg

Normal/MiRI low-dose group

Normal/MiRI high-dose group

Arm Description

DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Any Adjudicated Bleeding Events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01857622

First Posted

May 16, 2013

Last Updated

February 8, 2019

Sponsor

Daiichi Sankyo Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01857622

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-valvular Atrial Fibrillation

Keywords

anticoagulant, DU-176b, edoxaban, factor Xa, oral, atrial fibrillation, severe renal impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SRI 15mg

Arm Type

Experimental

Arm Description

DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

Arm Title

Normal/MiRI low-dose group

Arm Type

Experimental

Arm Description

Arm Title

Normal/MiRI high-dose group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

DU-176b 15mg

Other Intervention Name(s)

edoxaban

Intervention Description

oral DU-176b 15mg once daily

Intervention Type

Drug

Intervention Name(s)

DU-176b 30mg

Other Intervention Name(s)

edoxaban

Intervention Description

oral DU-176b 30mg once daily

Intervention Type

Drug

Intervention Name(s)

DU-176b 60mg

Other Intervention Name(s)

edoxaban

Intervention Description

oral DU-176b 60mg once daily

Primary Outcome Measure Information:

Title

Incidence of Any Adjudicated Bleeding Events

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yukihiro Koretsune, Dir

Organizational Affiliation

Osaka National Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tokyo Women's Medical University Hospital

City

Tokyo

ZIP/Postal Code

162-0054

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing URL

https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

We'll reach out to this number within 24 hrs