Clinical trial NCT00097357: BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Official title: A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Thrombosis
Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism
Preventive therapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-11-23
Enrollment: 1238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective unilateral total knee replacement surgery.
* Willing and able to undergo bilateral ascending contrast venography.
* Able to inject (by self or caregiver) study medication subcutaneously.

Exclusion Criteria:

* Women of childbearing potential.
* Women who are pregnant or breastfeeding.
* Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) \>=35 kg/m2

Primary outcomes:
measure: Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
timeFrame: throughout the study
Secondary outcomes:
measure: Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery
timeFrame: throughout the study
measure: Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
timeFrame: throughout the study
measure: Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
timeFrame: throughout the study
measure: To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
timeFrame: throughout the study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Northport
country: United States
facility: Local Institution
state: Alabama
city: Phoenix
country: United States
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state: Arizona
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Tucson
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state: Arizona
city: Little Rock
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facility: Local Institution
state: Arkansas
city: Beverly Hills
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facility: Local Institution
state: California
city: Encinitas
country: United States
facility: Local Institution
state: California
city: Fountain Valley
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facility: Local Institution
state: California
city: La Jolla
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state: California
city: La Mesa
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state: California
city: Long beach
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state: California
city: Montclair
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city: Oakland
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city: Pasadena
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city: Sacramento
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state: California
city: San Bernardino
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state: California
city: San Diego
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state: California
city: Santa Monica
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city: Torrance
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city: Aurora
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city: Denver
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city: Bay Pines
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city: Brandon
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city: Clearwater
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city: St. Petersburg
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city: Winter Park
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city: Atlanta
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city: Decatur
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city: Seattle
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city: Marshfield
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city: CAPITAL fEDERAL
country: Argentina
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state: Buenos Aires
city: Prov. Buenos Aires
country: Argentina
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state: Buenos Aires
city: Ciudad De Mendoza
country: Argentina
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state: Mendoza
city: Godoy Cruz
country: Argentina
facility: Local Institution
state: Mendoza
city: Buenos Aires
country: Argentina
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country: Australia
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state: New South Wales
city: Chermside
country: Australia
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state: Queensland
city: Gold Coast
country: Australia
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state: Queensland
city: Herston
country: Australia
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state: Queensland
city: Bedford Park
country: Australia
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state: South Australia
city: Box Hill
country: Australia
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state: Victoria
city: Clayton
country: Australia
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state: Victoria
city: East Ringwood
country: Australia
facility: Local Institution
state: Victoria
city: Geelong
country: Australia
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state: Victoria
city: Windsor
country: Australia
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state: Victoria
city: Calgary
country: Canada
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state: Alberta
city: Edmonton
country: Canada
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state: Alberta
city: Red Deer
country: Canada
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city: Kelowna
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Dartmouth
country: Canada
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state: Nova Scotia
city: Ajax
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city: Burlington
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city: Newmarket
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city: Waterloo
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city: Windsor
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city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Ste-foy
country: Canada
facility: Local Institution
state: Quebec
city: Victoriaville
country: Canada
facility: Local Institution
state: Quebec
city: Frederiksberg
country: Denmark
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city: Herlev
country: Denmark
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city: Horsholm
country: Denmark
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city: Silkeborg
country: Denmark
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city: Slagelse
country: Denmark
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city: Haifa
country: Israel
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city: Holon
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
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city: Petach-tikva
country: Israel
facility: Local Institution
city: Ramat Gan
country: Israel
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city: Rehovot
country: Israel
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city: Tel Aviv
country: Israel
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city: Zerifin
country: Israel
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city: Tijuana
country: Mexico
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state: Baja California Sur
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: Hermosillo
country: Mexico
facility: Local Institution
state: Sonora
city: Tampico, Tamps
country: Mexico
facility: Local Institution
state: Tamaulipas
city: Jalapa
country: Mexico
facility: Local Institution
state: Veracruz
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Chihuahua
country: Mexico
facility: Local Institution
city: Veracruz
country: Mexico
facility: Local Institution
city: Bialystock
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Lodz
country: Poland
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city: Lublin
country: Poland
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city: Piekary Slaskie
country: Poland
facility: Local Institution
city: Radom
country: Poland
facility: Local Institution
city: Sosnowiec
country: Poland
facility: Local Institution
city: Szczecin Zdunowo
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
Study officials:
References: