Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement (PEARL-1)

December 15, 2011 updated by: Astellas Pharma Inc

Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 14460
  • Japan
      • Chubu region, Japan
      • Chugoku region, Japan
      • Kansai region, Japan
      • Kanto region, Japan
      • Kyushyu region, Japan
      • Shikoku region, Japan
      • Tohoku region, Japan
  • Korea, Republic of
      • In Cheon, Korea, Republic of, 405-760
      • Jeonnam, Korea, Republic of, 519-809
      • Seoul, Korea, Republic of, 110-744
  • Malaysia
      • Kelantan, Malaysia, 16150
      • Kuala Lumpur, Malaysia, 59100
  • Philippines
      • Manila, Philippines, 1008
      • Quezon City, Philippines, 1114
  • Singapore
      • Singapore, Singapore
  • Taiwan
      • Kaohsiung, Taiwan, 833
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand, 50200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for elective primary total knee replacement surgery
  • Legal minimum age requirement ( country-specific)
  • Written informed consent has been obtained

Exclusion Criteria:

  • Documented history or considered to be at increased risk of venous thromboembolism

  • Subjects considered to be at increased risk of bleeding:

    • Known hemorrhagic disorder and/or coagulation disorder
    • Thrombocytopenia
    • Clinically important bleeding occurred within 3 months prior to the screening visit
  • Acute bacterial endocarditis
  • Severe hypertension
  • Retinopathy
  • Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: enoxaparin
Sub cutaneous
Experimental: 1
Dose regimen 1
Drug: YM150
Oral
Experimental: 3
Dose regimen 2
Drug: YM150
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
Time Frame: 2 Weeks
2 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Venous thromboembolism and/or bleeds
Time Frame: 2 Weeks
2 Weeks
Other safety assessments
Time Frame: 2 Weeks
2 Weeks
PK, PD variables
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 6, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 15, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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