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Completed

NCT Number: NCT00595426

A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Completed

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Key information

Conditions

Arthroplasty, Replacement, Knee Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Red Deer, Alberta, Canada

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 primary knee arthroplasty
  • Written Informed consent obtained

Exclusion criteria

  • Subject has documented history of previous VTE
  • Subject is considered to be at increased risk of VTE
  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Treatment and study plan

YM150

Drug

Oral

Warfarin

Drug

Oral

Primary outcomes

  1. The incidence of total venous thromboembolisms (VTE).

    Time frame: 6 Weeks

  2. The incidence of bleeding events classified as major by the Adjudication Committee

    Time frame: 6 Weeks

Secondary outcomes

  1. Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause

    Time frame: 6 Weeks

  2. Incidence of the bleeding types: major, clinically relevant nonmajor, minor

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty

Acronym: PEARL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
Mar 25, 2013

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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