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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595426
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 25, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: YM150 Drug: Warfarin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 685 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Warfarin
U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595426

  Hide Study 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, 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
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, 33703
St. Petersburg, Florida, United States, 33713
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, 79410
Lubbock, Texas, United States, 79412
Odessa, Texas, United States, 79761
San Antonio, Texas, United States, 78217
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23249
Richmond, Virginia, United States, 23294
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
Study Director: Central Contact Astellas Pharma Global Development

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00595426     History of Changes
Other Study ID Numbers: 150-CL-033
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: May 2010

Keywords provided by Astellas Pharma Inc:
Knee Arthroplasty
Factor Xa

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action