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A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Primary Purpose

Venous Thromboembolism, Thromboembolism, Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DU-176b 15mg
DU-176b 30mg
Enoxaparin sodium 20 mg (=2000IU)
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 prevention, venous thromboembolism, edoxaban, anticoagulants

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients undergoing unilateral total hip arthroplasty
  2. Patients who are 20-84 years olds

Exclusion Criteria:

  1. Subjects with risks of hemorrhage
  2. Subjects with thromboembolic risks
  3. Subjects who weigh less than 40 kg
  4. 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 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

DU-176b 30mg once daily

Enoxaparin sodium twice daily

DU-176b 15mg once daily

Arm Description

DU-176b 30 mg tablets, oral 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

DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery

Outcomes

Primary Outcome Measures

Percentage of Subjects With Venous Thromboembolism Events
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. Lower extremity DVT confirmed by bilateral venography at the end of study treatment Definite diagnosis of symptomatic PE Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE

Secondary Outcome Measures

Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.

Full Information

First Posted
September 14, 2010
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01203098
Brief Title
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Official Title
A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (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
The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Thromboembolism, Thrombosis, Embolism and Thrombosis, Deep Vein Thrombosis, Arthroplasty, Replacement, Hip
Keywords
prevention, venous thromboembolism, edoxaban, anticoagulants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DU-176b 30mg once daily
Arm Type
Experimental
Arm Description
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Arm Title
Enoxaparin sodium twice daily
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
Arm Title
DU-176b 15mg once daily
Arm Type
Experimental
Arm Description
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Intervention Type
Drug
Intervention Name(s)
DU-176b 15mg
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
DU-176b 30mg
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin sodium 20 mg (=2000IU)
Intervention Description
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Venous Thromboembolism Events
Description
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. Lower extremity DVT confirmed by bilateral venography at the end of study treatment Definite diagnosis of symptomatic PE Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing unilateral total hip arthroplasty Patients who are 20-84 years olds Exclusion Criteria: Subjects with risks of hemorrhage Subjects with thromboembolic 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 Koseinenkin Hospital
Official's Role
Principal Investigator
Facility Information:
City
Osaka
Country
Japan
City
Tokyo
Country
Japan
City
Kaohsiung
Country
Taiwan

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
25047458
Citation
Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. J Arthroplasty. 2014 Dec;29(12):2439-46. doi: 10.1016/j.arth.2014.05.029. Epub 2014 Jun 9.
Results Reference
derived

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A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

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