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Completed

NCT Number: NCT01181141

Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DU-176b (edoxaban)

Drug

Enoxaparin sodium 20mg

Drug

Primary outcomes

  1. The Incidence of Major or Clinically Relevant Non-major Bleeding

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Proportion of Subjects With Venous Thromboembolism Events.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 13, 2010
Registry last updated
Mar 5, 2019

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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