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

January 7, 2008
March 19, 2013
May 2008
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00595426 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptotomatic 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 ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Arthroplasty, Replacement, Knee
  • Drug: YM150
    Oral
  • Drug: Warfarin
    Oral
  • Experimental: 1. YM150 Dose X, twice daily
    Intervention: Drug: YM150
  • Experimental: 2. YM150 Dose Y, once daily
    Intervention: Drug: YM150
  • Experimental: 3. YM150 Dose Y, twice daily
    Intervention: Drug: YM150
  • Experimental: 4. YM150 Dose Z, once daily
    Intervention: Drug: YM150
  • Active Comparator: 5. Warfarin
    various doses
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
685
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00595426
150-CL-033
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP