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Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement (PEARL-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00408239
First received: December 4, 2006
Last updated: December 15, 2011
Last verified: December 2011
History of Changes

December 4, 2006
December 15, 2011
December 2006
March 2009   (final data collection date for primary outcome measure)
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00408239 on ClinicalTrials.gov Archive Site
  • Venous thromboembolism and/or bleeds [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
  • Other safety assessments [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • PK, PD variables [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Thromboembolism
  • Drug: YM150
    Oral
  • Drug: enoxaparin
    Sub cutaneous
  • Experimental: 1
    Dose regimen 1
    Intervention: Drug: YM150
  • Active Comparator: 2
    Intervention: Drug: enoxaparin
  • Experimental: 3
    Dose regimen 2
    Intervention: Drug: YM150
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for elective primary total knee replacement surgery
  • Legal minimum age requirement ( country-specific)
  • Written informed consent has been obtained

Exclusion Criteria:

  • Documented history or considered to be at increased risk of venous thromboembolism

  • Subjects considered to be at increased risk of bleeding:

    • Known hemorrhagic disorder and/or coagulation disorder
    • Thrombocytopenia
    • Clinically important bleeding occurred within 3 months prior to the screening visit
  • Acute bacterial endocarditis
  • Severe hypertension
  • Retinopathy
  • Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
 
NCT00408239
150-CL-029
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
December 2011

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