A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery (PEARL)
This study has been completed.
Sponsor:
Astellas Pharma Inc
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
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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:
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
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Hide Study LocationsLocations
| United States, Alabama | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85023 | |
| Tuscon, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Fountain Valley, California, United States, 92708 | |
| La Mesa, California, United States, 91942 | |
| Long Beach, California, United States, 90822 | |
| Long Beach, California, United States, 90806 | |
| San Diego, California, United States, 92128 | |
| Santa Ana, California, United States, 92074 | |
| Torrance, California, United States, 90502 | |
| Yuba City, California, United States, 95991 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80012 | |
| Denver, Colorado, United States, 80230 | |
| Lone Tree, Colorado, United States, 80124 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20017 | |
| United States, Florida | |
| Bay Pines, Florida, United States, 33744 | |
| Bradenton, Florida, United States, 34209 | |
| Gulf Breeze, Florida, United States, 32561 | |
| Hollywood, Florida, United States, 33021 | |
| St. Petersburg, Florida, United States, 33713 | |
| St. Petersburg, Florida, United States, 33703 | |
| United States, Georgia | |
| Decatur, Georgia, United States, 30033 | |
| Savannah, Georgia, United States, 31405 | |
| United States, Idaho | |
| Boise, Idaho, United States, 83702 | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Springfield, Illinois, United States, 62703 | |
| Springfield, Illinois, United States, 62794 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21218 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45242 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States, 74146 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Texas | |
| Austin, Texas, United States, 78745 | |
| Dallas, Texas, United States, 75231 | |
| Grapevine, Texas, United States, 76051 | |
| Houston, Texas, United States, 77030 | |
| Lubbock, Texas, United States, 79412 | |
| Lubbock, Texas, United States, 79410 | |
| Odessa, Texas, United States, 79761 | |
| San Antonio, Texas, United States, 78217 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
| Richmond, Virginia, United States, 23249 | |
| Canada, Alberta | |
| Red Deer, Alberta, Canada, T4N 4E7 | |
| Canada, Ontario | |
| Ajax, Ontario, Canada, L1S 2J5 | |
| Burlington, Ontario, Canada, L7R 4B7 | |
| Montreal, Ontario, Canada, H1T 2M4 | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Scarborough, Ontario, Canada, M1E 5E9 | |
| St. Catherines, Ontario, Canada, L2R 7P3 | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Waterloo, Ontario, Canada, N2J 1CA | |
| Canada, Prince Edward Island | |
| Charlottetown, Prince Edward Island, Canada, C1A 1L2 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Central Contact | Astellas Pharma Global Development |
More Information
Additional Information:
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 May 16, 2013