A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery
PEARL
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
1 other identifier
interventional
685
2 countries
54
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2008
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMarch 25, 2013
May 1, 2010
1 year
January 7, 2008
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of total venous thromboembolisms (VTE).
6 Weeks
The incidence of bleeding events classified as major by the Adjudication Committee
6 Weeks
Secondary Outcomes (2)
Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause
6 Weeks
Incidence of the bleeding types: major, clinically relevant nonmajor, minor
6 Weeks
Study Arms (5)
1. YM150 Dose X, twice daily
EXPERIMENTAL2. YM150 Dose Y, once daily
EXPERIMENTAL3. YM150 Dose Y, twice daily
EXPERIMENTAL4. YM150 Dose Z, once daily
EXPERIMENTAL5. Warfarin
ACTIVE COMPARATORvarious doses
Interventions
Eligibility Criteria
You may qualify if:
- Subject is scheduled for elective primary knee arthroplasty
- Written Informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85023, United States
Unknown Facility
Tuscon, Arizona, 85712, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
Santa Ana, California, 92074, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Yuba City, California, 95991, United States
Unknown Facility
Aurora, Colorado, 80012, United States
Unknown Facility
Denver, Colorado, 80230, United States
Unknown Facility
Lone Tree, Colorado, 80124, United States
Unknown Facility
Washington D.C., District of Columbia, 20017, United States
Unknown Facility
Bay Pines, Florida, 33744, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Gulf Breeze, Florida, 32561, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
St. Petersburg, Florida, 33703, United States
Unknown Facility
St. Petersburg, Florida, 33713, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Savannah, Georgia, 31405, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Springfield, Illinois, 62794, United States
Unknown Facility
Baltimore, Maryland, 21218, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Tulsa, Oklahoma, 74146, United States
Unknown Facility
Charleston, South Carolina, 29414, United States
Unknown Facility
Austin, Texas, 78745, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Grapevine, Texas, 76051, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Lubbock, Texas, 79410, United States
Unknown Facility
Lubbock, Texas, 79412, United States
Unknown Facility
Odessa, Texas, 79761, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Red Deer, Alberta, T4N 4E7, Canada
Unknown Facility
Ajax, Ontario, L1S 2J5, Canada
Unknown Facility
Burlington, Ontario, L7R 4B7, Canada
Unknown Facility
Montreal, Ontario, H1T 2M4, Canada
Unknown Facility
Newmarket, Ontario, L3Y 2P9, Canada
Unknown Facility
Saint Catherines, Ontario, L2R 7P3, Canada
Unknown Facility
Scarborough Village, Ontario, M1E 5E9, Canada
Unknown Facility
Thunder Bay, Ontario, P7B 6V4, Canada
Unknown Facility
Waterloo, Ontario, N2J 1CA, Canada
Unknown Facility
Charlottetown, Prince Edward Island, C1A 1L2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 25, 2013
Record last verified: 2010-05