NCT01181141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

August 12, 2010

Results QC Date

January 15, 2015

Last Update Submit

February 8, 2019

Conditions

Venous Thromboembolism

Keywords

AnticoagulantsEnoxaparin sodiumvenous thromboembolism.thromboembolismThrombosisdeep vein thrombosisDU-176bEdoxabanfactor Xahip fracture surgeryembolism

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (1)

  • Proportion of Subjects With Venous Thromboembolism Events.

    2 weeks

Study Arms (2)

DU-176b

EXPERIMENTAL

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

Drug: DU-176b (edoxaban)

Enoxaparin sodium

ACTIVE COMPARATOR

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

Drug: Enoxaparin sodium 20mg

Interventions

DU-176b (edoxaban)DRUG
DU-176b
Enoxaparin sodium 20mgDRUG
Enoxaparin sodium

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24680549DERIVED

MeSH Terms

Conditions

Venous ThromboembolismThromboembolismThrombosisVenous ThrombosisEmbolism

Interventions

edoxabanenoxaparin sodium

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Kenichi Sakakura, Manager
Organization
Daiichi Sankyo.,LTD
sakakura.kenichi.ef@daiichisankyo.co.jp
81-90-1885-0271

Study Officials

  • Takeshi Fuji

    Osaka Kouseinennkin Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

October 1, 2008

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

March 5, 2019

Results First Posted

January 26, 2015

Record last verified: 2015-02

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
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.
More information

Locations

JP(1)