search
Back to results

Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DU-176b (edoxaban)
Enoxaparin sodium 20mg
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, hip fracture surgery, embolism

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

  • Subjects with risks of hemorrhage
  • Subjects with thrombolic risks
  • Subjects who weigh less than 40 kg
  • Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DU-176b

Enoxaparin sodium

Arm Description

DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery

Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery

Outcomes

Primary Outcome Measures

The Incidence of Major or Clinically Relevant Non-major Bleeding
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

Secondary Outcome Measures

Proportion of Subjects With Venous Thromboembolism Events.

Full Information

First Posted
August 12, 2010
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01181141
Brief Title
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
Official Title
A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, hip fracture surgery, embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DU-176b
Arm Type
Experimental
Arm Description
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery
Arm Title
Enoxaparin sodium
Arm Type
Active Comparator
Arm Description
Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
Intervention Type
Drug
Intervention Name(s)
DU-176b (edoxaban)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin sodium 20mg
Primary Outcome Measure Information:
Title
The Incidence of Major or Clinically Relevant Non-major Bleeding
Description
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Venous Thromboembolism Events.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric) Exclusion Criteria: Subjects with risks of hemorrhage Subjects with thrombolic risks Subjects who weigh less than 40 kg Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Fuji
Organizational Affiliation
Osaka Kouseinennkin Hospital
Official's Role
Principal Investigator
Facility Information:
City
Osaka
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/
Citations:
PubMed Identifier
24680549
Citation
Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.
Results Reference
derived

Learn more about this trial

Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

We'll reach out to this number within 24 hrs