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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595426

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

Additional Information:
Link to results on JAPIC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00595426     History of Changes
Other Study ID Numbers: 150-CL-033
Study First Received: January 7, 2008
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013