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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hip Fractures

Intervention: enoxaparin (XRP4563) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: bleeding events

Secondary outcome: incidence of venous thromboembolism

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Sanofi- Aventis Administrative Office, Tokyo, Japan
Additional Information

Starting date: July 2006
Last updated: October 1, 2009

Page last updated: August 23, 2015

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