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

March 19, 2013 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

685

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

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 4E7
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
      • Burlington, Ontario, Canada, L7R 4B7
      • Montreal, Ontario, Canada, H1T 2M4
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Scarborough, Ontario, Canada, M1E 5E9
      • St. Catherines, Ontario, Canada, L2R 7P3
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Waterloo, Ontario, Canada, N2J 1CA
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 1L2
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85023
      • Tuscon, Arizona, United States, 85712
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fountain Valley, California, United States, 92708
      • La Mesa, California, United States, 91942
      • Long Beach, California, United States, 90806
      • Long Beach, California, United States, 90822
      • San Diego, California, United States, 92128
      • Santa Ana, California, United States, 92074
      • Torrance, California, United States, 90502
      • Yuba City, California, United States, 95991
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Denver, Colorado, United States, 80230
      • Lone Tree, Colorado, United States, 80124
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Bradenton, Florida, United States, 34209
      • Gulf Breeze, Florida, United States, 32561
      • Hollywood, Florida, United States, 33021
      • St. Petersburg, Florida, United States, 33713
      • St. Petersburg, Florida, United States, 33703
    • Georgia
      • Decatur, Georgia, United States, 30033
      • Savannah, Georgia, United States, 31405
    • Idaho
      • Boise, Idaho, United States, 83702
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Springfield, Illinois, United States, 62703
      • Springfield, Illinois, United States, 62794
    • Maryland
      • Baltimore, Maryland, United States, 21218
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44195
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
    • South Carolina
      • Charleston, South Carolina, United States, 29414
    • Texas
      • Austin, Texas, United States, 78745
      • Dallas, Texas, United States, 75231
      • Grapevine, Texas, United States, 76051
      • Houston, Texas, United States, 77030
      • Lubbock, Texas, United States, 79410
      • Lubbock, Texas, United States, 79412
      • Odessa, Texas, United States, 79761
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78217
    • Virginia
      • Richmond, Virginia, United States, 23249
      • Richmond, Virginia, United States, 23294

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:

  • 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. YM150 Dose X, twice daily
Drug: YM150
Oral
Experimental: 2. YM150 Dose Y, once daily
Drug: YM150
Oral
Experimental: 3. YM150 Dose Y, twice daily
Drug: YM150
Oral
Experimental: 4. YM150 Dose Z, once daily
Drug: YM150
Oral
Active Comparator: 5. Warfarin
various doses
Drug: Warfarin
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of total venous thromboembolisms (VTE).
Time Frame: 6 Weeks
6 Weeks
The incidence of bleeding events classified as major by the Adjudication Committee
Time Frame: 6 Weeks
6 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause
Time Frame: 6 Weeks
6 Weeks
Incidence of the bleeding types: major, clinically relevant nonmajor, minor
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-033

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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