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Completed

NCT Number: NCT00685958

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

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

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Key information

Conditions

Hip Fractures Cardiovascular Diseases Embolism and Thrombosis Femoral Fractures Fractures, Bone Hemorrhage Hip Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi- Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enoxaparin (XRP4563)

Drug

14 days of treatment

Primary outcomes

  1. bleeding events

    Time frame: 28 days

Secondary outcomes

  1. incidence of venous thromboembolism

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 29, 2008
Registry last updated
Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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