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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01181141
Other study ID # DU176b-B-J303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2008
Est. completion date February 2010

Study information

Verified date February 2015
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date February 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DU-176b (edoxaban)

Enoxaparin sodium 20mg


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion of Subjects With Venous Thromboembolism Events. 2 weeks
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