Clinical trial NCT00595426: A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee Arthroplasty
Factor Xa
VTE
Thrombosis
Anticoagulants
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: The incidence of total venous thromboembolisms (VTE).
timeFrame: 6 Weeks
measure: The incidence of bleeding events classified as major by the Adjudication Committee
timeFrame: 6 Weeks
Secondary outcomes:
measure: Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause
timeFrame: 6 Weeks
measure: Incidence of the bleeding types: major, clinically relevant nonmajor, minor
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lone Tree
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Bay Pines
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Red Deer
country: Canada
state: Alberta
city: Ajax
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: St. Catherines
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Charlottetown
country: Canada
state: Prince Edward Island
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References: