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

  Show 54 Study Locations
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