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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00595426
First received: January 7, 2008
Last updated: March 19, 2013
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Drug: YM150
Drug: Warfarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The incidence of total venous thromboembolisms (VTE). [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The incidence of bleeding events classified as major by the Adjudication Committee [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Incidence of the bleeding types: major, clinically relevant nonmajor, minor [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 685
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595426

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85023
Tuscon, Arizona, United States, 85712
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Fountain Valley, California, United States, 92708
La Mesa, California, United States, 91942
Long Beach, California, United States, 90822
Long Beach, California, United States, 90806
San Diego, California, United States, 92128
Santa Ana, California, United States, 92074
Torrance, California, United States, 90502
Yuba City, California, United States, 95991
United States, Colorado
Aurora, Colorado, United States, 80012
Denver, Colorado, United States, 80230
Lone Tree, Colorado, United States, 80124
United States, District of Columbia
Washington, District of Columbia, United States, 20017
United States, 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
United States, Georgia
Decatur, Georgia, United States, 30033
Savannah, Georgia, United States, 31405
United States, Idaho
Boise, Idaho, United States, 83702
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Springfield, Illinois, United States, 62703
Springfield, Illinois, United States, 62794
United States, Maryland
Baltimore, Maryland, United States, 21218
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Tulsa, Oklahoma, United States, 74146
United States, South Carolina
Charleston, South Carolina, United States, 29414
United States, 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, 79412
Lubbock, Texas, United States, 79410
Odessa, Texas, United States, 79761
San Antonio, Texas, United States, 78217
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23294
Richmond, Virginia, United States, 23249
Canada, Alberta
Red Deer, Alberta, Canada, T4N 4E7
Canada, 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
Canada, Prince Edward Island
Charlottetown, Prince Edward Island, Canada, C1A 1L2
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00595426     History of Changes
Other Study ID Numbers: 150-CL-033
Study First Received: January 7, 2008
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Knee Arthroplasty
Factor Xa
VTE
Thrombosis
Anticoagulants

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014