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Completed

NCT Number: NCT00902928

A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Box Hill, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is scheduled for elective hip replacement surgery

Exclusion criteria

  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
  • Subject has had an MI or stroke within 3 months before planned hip replacement surgery

Treatment and study plan

YM150

Drug

oral

Enoxaparin

Drug

SC injection

Primary outcomes

  1. Incidence of symptomatic Venous Thromboembolisms and death from all causes

    Time frame: 12 days

Secondary outcomes

  1. Incidence of all Venous Thromboembolic events

    Time frame: Until day 12, during the treatment period, follow-up period and entire study period

  2. Incidence of Bleeding events

    Time frame: During the treatment period, follow-up period and entire study period

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

Acronym: ONYX-3

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 15, 2009
Registry last updated
Oct 27, 2015

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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