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NCT Number: NCT01203098

A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

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Key information

Conditions

Venous Thromboembolism Arthroplasty, Replacement, Hip Cardiovascular Diseases Deep Vein Thrombosis Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing unilateral total hip arthroplasty
  • Patients who are 20-84 years olds

Exclusion criteria

  • Subjects with risks of hemorrhage
  • Subjects with thromboembolic 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 15mg

Drug

DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.

Other names: edoxaban

DU-176b 30mg

Drug

DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.

Other names: edoxaban

Enoxaparin sodium 20 mg (=2000IU)

Drug

Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.

Primary outcomes

  1. Percentage of Subjects With Venous Thromboembolism Events

    Time frame: 2 weeks

    The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.

    • Lower extremity DVT confirmed by bilateral venography at the end of study treatment
    • Definite diagnosis of symptomatic PE
    • Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE

Secondary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 16, 2010
Registry last updated
Feb 25, 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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