Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery

Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00685958

Enrollment

Registered

2008-05-29

Start date

2006-07-31

Completion date

2007-03-31

Last updated

2009-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

Blood thinner, enoxaparin, hip fracture surgery, bleeding, thromboembolism

Brief summary

The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Interventions

DRUGenoxaparin (XRP4563)

14 days of treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* femoral neck inside or outside fracture

Exclusion criteria

* any major surgery on lower limbs within 3 months * clinical signs of deep vein thrombosis * use of non-steroidal anti-inflammatory drugs * severe hepatic disease or renal insufficiency

Design outcomes

Primary

Measure	Time frame
bleeding events	28 days

Secondary

Measure	Time frame
incidence of venous thromboembolism	28 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026