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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00595426
First Posted: January 16, 2008
Last Update Posted: March 25, 2013
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
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

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 ]
  • The incidence of bleeding events classified as major by the Adjudication Committee [ Time Frame: 6 Weeks ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00595426


  Show 54 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00595426     History of Changes
Other Study ID Numbers: 150-CL-033
First Submitted: January 7, 2008
First Posted: January 16, 2008
Last Update Posted: March 25, 2013
Last Verified: May 2010

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

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